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| Model Number |
CH07-40-75US |
| Medical Device Problem Code |
Detachment of Device or Device Component (2907)
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| Health Effect - Clinical Codes |
Aneurysm (1708); Stenosis (2263); Pseudoaneurysm (2605); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
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| Date of Event |
06/16/2022
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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According to the reporter, the patient was 64 years old and on hemodialysis at the dci ((b)(4)) carondelet dialysis unit.The patient had a left upper arm loop brachiobasilic graft with median vein configuration.The patient came in for increased bleeding from the graft.The patient had an angioplasty of the venous end of the graft performed by kansas city interventional group.It was said that the patient was informed and an informed consent for the procedure was obtained.The patient was then taken to the operating room.Left arm was prepped and draped.Lidocaine 1% was injected proximally and cannulation of the graft was performed using a 21-gauge micro puncture needle.A guidewire was placed across the needle and a 5-french sheath was advanced over the wire.Introducer and the wire were removed.Sheath was flushed with saline.Good blood flow was obtained.Diluted dye was injected into the fistula demonstrated widely patent fistula proximally in the distal end of the arterial limb and noticed a pseudoaneurysm in the distal portion of the graft corresponding to frequent cannulation in the same site with residual thrombus in the aneurysm.The distal end of the aneurysm had a mild stenosis, around 30-40%.The rest of the graft appeared widely patent.There was a stent across the venous anastomosis which was patent.There was a mild stenosis, 10-15%, in the basilic vein, but not flow-limiting.The rest of the central circulation was patent.The patient was informed.They gave the patient versed 2mg (sedation), the sedation time was 25 minutes, the patient was observed and monitored while under moderate sedation by the trained nurse for the duration of the procedure.A glidewire was placed across the 5-fr sheath and exchanged for a 7mmx40mm balloon; physician was going sheath-less in the out flow and had a resistance getting it into the vessel.It was said that on attempts to perform angioplasty, as they were feeding the balloon over the wire, they noticed that the balloon had completely came/broke off from the shaft with some part of it lodged in the graft wall.They left the wire with the remnant of the balloon in there and immediately performed a second cannulation more distal in the graft, in the retrograde direction towards the arterial anastomosis using a 21-gauge needle.A glidewire was placed across the 5-french sheath and was exchanged for an 8-french side-port sheath.Holding it in place, a 7mmx60mm covera straight stent was prepared, deployed across the body of the balloon (to get the balloon against the wall of the graft) and was stretched using the 7mm balloon, draining off the balloon remnant in between the stent and the body of the graft.Post angiogram confirmed the findings of the gelling of the balloon remnant and the good flow of contrast in that area.Then, they advanced the 7mm balloon to the distal area of the pseudoaneurysm and the thrombus.Angioplasty was then performed.Moderate waist was noted.Balloon was held at full effacement at 20 atmospheres for 30 seconds x2.Post angiogram revealed marked improvement in the stenosis and good flow in that area with minimal residual thrombus.The graft was widely patent after the procedure was performed and stent was placed.The procedure was then concluded.The sheath was removed and hemostasis was achieved by applying two stitches.The device was not repaired and had no leak.The device was flushed with saline - cleaning agent used.The insertion site was treated with chloraprep prior to product placement.Tego was not utilized.6ml of undiluted dye was used.There was no luer adapter issue.The patient was taken to the postop room in satisfactory condition.Also, it was said that the patient was not injured, but a portion of the balloon was still in patient using the said stent to hold it against the patient's av (arteriovenous) access graft and might need surgery to have it remove.
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Additional Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Additional Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event or Problem Description
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According to the reporter, the patient was 64 years old and on hemodialysis at the (b)(6)((b)(6) inc.) carondolet dialysis unit.The patient had a left upper arm loop brachiobasilic graft with median vein configuration.The patient came in for increased bleeding from the graft.The patient had an angioplasty of the venous end of the graft performed by (b)(6) group.It was said that the patient was informed and an informed consent for the procedure was obtained.The patient was then taken to the operating room.Left arm was prepped and draped.Lidocaine 1% was injected proximally and cannulation of the graft was performed using a 21-gauge micro puncture needle (a micro puncture set).A.035 glidewire was placed across the needle and a 5-french sheath was advanced over the wire.Introducer and the wire were removed.Sheath was flushed with saline.Good blood flow was obtained.Diluteddye was injected into the fistula demonstrated widely patent fistula proximally in the distal end of the arterial limb and noticed a pseudoaneurysm in the distal portion of the graft corresponding to frequent cannulation in the same site with residual thrombus in the pseudoaneurysm.The distal end of the pseudoaneurysm had a mild stenosis, around 30-40%.The rest of the graft appeared widely patent.There was a stent across the venous anastomosis which was patent.There was a mild stenosis,10-15%, in the basilic vein, but not flow-limiting.The rest of the central circulation was patent.The patient was informed.They gave the patient versed 2mg (sedation), the sedation time was 25 minutes, the patient was observed and monitored while under moderate sedation by the trained nurse for the duration of the procedure.A glidewire was placed across the 5-fr sheath and exchanged for a 7mmx40mm balloon; physician was going sheath-less in the out flow and had a resistance getting it into the vessel.It was said that on attempts to perform angioplasty, as they were feeding the balloon over the wire, they noticed that the balloon had completely came/broke off from the shaft with some part of it lodged in the graft wall (balloon broke off right after insertion, never had the ability to inflate).The device did not pass through a previously deployed stent, it just made right passed the insertion site and broke off in the graft (traveled just far enough to make it in the body and be left behind).They left the wire with the remnant of the balloon in there and immediately performed a second cannulation more distal in the graft, in the retrograde direction towards the arterial anastomosis using a 21- gauge needle.A glidewire was placed across the 5-french sheath and was exchanged for an 8-french side-port sheath.Holding it in place, a 7mmx60mm covera straight stent was prepared, deployed across the body of the balloon (to get the balloon against the wall of the graft) and after the stent was deployed a gladator 7 x 4 balloon was used to fully expand/stretch the stent, draining off the balloon remnant in between the stent and the body of the graft.Post angiogram confirmed the findings of the gelling of the balloon remnant and the good flow of contrast in that area.Then, they advanced the 7mm balloon to the distal area of the pseudoaneurysm and the thrombus.Angioplasty was then performed.Moderate waist was noted.Balloon was held at full effacement at 20 atmospheres for 30 seconds x2.Post angiogram revealed marked improvement in the stenosis and good flow in that area with minimal residual thrombus.The graft was widely patent after the procedure was performed and stent was placed.The procedure was then concluded.The sheath was removed and hemostasis was achieved by applying two stitches.Nothing unusual was observed on the device prior to use.The device was not repaired and had no leak.The device was flushed with saline per ifu (instruction for use) with normal results and used also as cleaning agent.The insertion site was treated with cloraprep prior to product placement.Tego was not utilized.A total of 6ml of contrast was used, but was diluted when injected with saline.There was no luer adapter issue.Resistance was encountered when advancing the device on the 1st attempt (there was no 2nd attempt).Excessive force was used during entry and the balloon was already broke off when the balloon shaft was withdrawn.There was no blood loss and no blood transfusion was required.The patient was taken to the postop room in satisfactory condition.The patient did not receive an additional, unplanned therapies or treatments as a result of this event.No medication provided for the pseudoaneurysm with some thrombus on it.Also, it was said that the patient was not injured, but a portion of the balloon was still in patient using the said stent to hold it against the patient's av (arteriovenous) access graft and might need a surgery to have it removed but the patient did not yet receive the surgery.There was no additional medical intervention required to retrieve the remaining portion at this time.
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Additional Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event or Problem Description
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According to the reporter, the patient was on hemodialysis at the dci (dialysis clinic, inc.) carondolet dialysis unit.The patient had a left upper arm loop brachiobasilic graft with median vein configuration.The patient came in for increased bleeding from the graft.The patient had an angioplasty of the venous end of the graft performed by kansas city interventional group.It was said that the patient was informed and an informed consent for the procedure was obtained.The patient was then taken to the operating room.Left arm was prepped and draped.Lidocaine 1% was injected proximally and cannulation of the graft was performed using a 21-gauge micro puncture needle - a micro puncture set (cook micro puncture set has an 18 gauge needle and a 5 french sheath for injecting contrast through to get initial images, once the images were obtained, a wire was put back through the sheath, sheath was removed and balloon was placed over the wire).A.035 glidewire (guidewire) was placed across the needle and a 5-french sheath was advanced over the wire.Introducer and the wire were removed.Sheath was flushed with saline (sheath was used for imaging alone).Good blood flow was obtained.Diluted dye was injected into the fistula demonstrated widely patent fistula proximally in the distal end of the arterial limb and noticed a pseudoaneurysm in the distal portion of the graft corresponding to frequent cannulation in the same site with residual thrombus in the pseudoaneurysm.The distal end of the pseudoaneurysm had a mild stenosis, around 30-40%.The rest of the graft appeared widely patent.There was a stent across the venous anastomosis which was patent.There was a mild stenosis,10-15%, in the basilic vein, but not flow-limiting.The rest of the central circulation was patent.The patient was informed.They gave the patient versed 2mg (sedation), the sedation time was 25 minutes, the patient was observed and monitored while under moderate sedation by the trained nurse for the duration of the procedure.A glidewire was placed across the 5-fr sheath and exchanged for a 7mmx40mm balloon; physician was going sheath-less (sheath was not used with the balloon, but guidewire was) in the out flow and had a resistance getting it into the vessel.It was said that on attempts to perform angioplasty, as they were feeding the balloon over the wire, they noticed that the balloon had completely came/broke off from the shaft with some part of it lodged in the graft wall (balloon broke off right after insertion, never had the ability to inflate).The device did not pass through a previously deployed stent, it just made right passed the insertion site and broke off in the graft (traveled just far enough to make it in the body and be left behind).They left the wire with the remnant of the balloon in there and immediately performed a second cannulation more distal in the graft, in the retrograde direction towards the arterial anastomosis using a 21-gauge needle.A glidewire was placed across the 5-french sheath and was exchanged for an 8-french side-port sheath.Holding it in place, a 7mmx60mm covera straight stent was prepared, deployed across the body of the balloon (to get the balloon against the wall of the graft) and after the stent was deployed a gladator 7 x 4 balloon was used to fully expand/stretch the stent, draining off the balloon remnant in between the stent and the body of the graft.Post angiogram confirmed the findings of the gelling of the balloon remnant and the good flow of contrast in that area.Then, they advanced the 7mm balloon to the distal area of the pseudoaneurysm and the thrombus.Angioplasty was then performed.Moderate waist was noted.Balloon was held at full effacement at 20 atmospheres for 30 seconds x2.Post angiogram revealed marked improvement in the stenosis and good flow in that area with minimal residual thrombus.The graft was widely patent after the procedure was performed and stent was placed.The procedure was then concluded.The sheath was removed and hemostasis was achieved by applying two stitches.Nothing unusual was observed on the device prior to use.The device was not repaired and had no leak.The device was flushed with saline per ifu (instruction for use) with normal results and used also as cleaning agent.The insertion site was treated with cloraprep prior to product placement.Tego was not utilized.A total of 6ml of contrast was used, but was diluted when injected with saline.There was no luer adapter issue.Resistance was encountered when advancing the device on the 1st attempt (there was no 2nd attempt).Excessive force was used during entry and the balloon was already broke off when the balloon shaft was withdrawn.There was no blood loss and no blood transfusion was required.The patient was taken to the postop room in satisfactory condition.The patient did not received an additional, unplanned therapies or treatments as a result of this event.No medication provided for the pseudoaneurysm with some thrombus on it.Also, it was said that the patient was not injured, but a portion of the balloon was still remain in patient using the said covered stent to hold it and keep it in place against the patient's av (arteriovenous) access graft (no changes in patient's condition).They did not remove the balloon and the patient never had additional surgery to remove it (no additional medical intervention required to retrieve the remaining portion).As of august 4, the patient was going well.
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Additional Manufacturer Narrative
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Additional information: a1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the balloon was detached from the cannula and was not returned.Additionally, at the distal end of the cannula, the infusion plate was not aligned with the port hole.It was reported that there was detachment of the balloon.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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