MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145018

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to procedure, flushing was done successfully.During insertion at the right femoral vein, catheter tip was not passing through the tip of the pull apart sheath, before the catheter was inserted, after repeated attempts, the pull apart sheath bent, split midway (at the middle), stayed in the patient body for a few minutes.No additional surgical procedure required.Both parts were retrievable, retrieved manually with help of forceps on the same day of the event, x-ray machine performed to make sure all the pieces were retrieved, and all pieces were accounted for.Following the pull apart sheath fault, the catheter was removed and new catheter with similar model number and same lot was used on the same day of the event, the pull apart sheath was discarded, a new sheath came from the replacement kit utilized, the new catheter was successfully inserted on the same insertion site, subsequently good back flow was also observed and the procedure was completed.No resistance encountered and no excessive force used when inserting the catheter tip to the pull apart sheath.There was no leak from valve of the sheath, there was no attempt to split the pull apart sheath prior to sheath break and the pull apart sheath used the one included in the kit.The dimension of the catheter and sheath matched what was indicated on the label, there was no problem with the catheter's dimension and no visual defect/damage noted on the catheter or on the catheter tip.The catheter was not repaired, no leak, tego was not utilized, there was no luer adapter issue, betadine and chlorhexidine were the cleaning agents used on the device.Betadine was the solution/agent used on the insertion site prior to product placement.The issue did not lead to vessel/vein damage.The patient did not have air embolism.There was 5-10ml of blood loss, blood transfusion was not required, and no other intervention/treatment required as a result of the event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to procedure, flushing was done successfully.During insertion at the right femoral vein, catheter tip was not passing through the tip of the pull apart sheath, before the catheter was inserted, after repeated attempts, the pull apart sheath bent, split midway (at the middle), stayed in the patient body for a few minutes.No additional surgical procedure required.Both parts were retrievable, retrieved manually with help of forceps on the same day of the event, x-ray machine performed to make sure all the pieces were retrieved, and all pieces were accounted for.Following the pull apart sheath fault, the catheter was removed and new catheter with similar model number and same lot was used on the same day of the event, the pull apart sheath was discarded, a new sheath came from the replacement kit utilized, the new catheter was successfully inserted on the same insertion site, subsequently good back flow was also observed and the procedure was completed.No resistance encountered and no excessive force used when inserting the catheter tip to the pull apart sheath.There was no leak from valve of the sheath, there was no attempt to split the pull apart sheath prior to sheath break and the pull apart sheath used the one included in the kit.The dimension of the catheter and sheath matched what was indicated on the label, there was no problem with the catheter's dimension and no visual defect/damage noted on the catheter or on the catheter tip.The catheter was not repaired, no leak, tego was not utilized, there was no luer adapter issue, betadine and chlorhexidine were the cleaning agents used on the device.Betadine was the solution/agent used on the insertion site prior to product placement.The issue did not lead to vessel/vein damage.The patient did not have air embolism.There was 5-10ml of blood loss, blood transfusion was not required, and no other intervention/treatment required as a result of the event.

Manufacturer Narrative

Additional information: b5, g3.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.

Event Description

According to the reporter, prior to procedure, flushing was done successfully.During insertion at the right femoral vein, catheter tip was not passing through the tip of the pull apart sheath.Before the catheter was inserted, after repeated attempts, the pull apart sheath bent, split midway (at the middle), stayed in the patient body for a few minutes.No additional surgical procedure required.Both parts were retrievable, retrieved manually with help of forceps on the same day of the event.All parts were removed on same procedure, it took few minutes to remove both parts, x-ray machine was performed to make sure all the pieces were retrieved, all pieces were accounted for, and the x-ray was done in addition due to pull apart sheath issue.Following the pull apart sheath fault, the catheter was removed and new catheter with similar model number and same lot was used on the same day of the event, the pull apart sheath was discarded, a new sheath came from the replacement kit utilized, the new catheter was successfully inserted on the same insertion site, subsequently good back flow was also observed and the procedure was completed.No resistance encountered and no e xcessive force used when inserting the catheter tip to the pull apart sheath.There was no leak from valve of the sheath, there was no attempt to split the pull apart sheath prior to sheath break and the pull apart sheath used the one included in the kit.The dimension of the catheter and sheath matched what was indicated on the label, there was no problem with the catheter's dimension and no visual defect/damage noted on the catheter or on the catheter tip.The catheter was not repaired, no leak, tego was not utilized, there was no luer adapter issue, betadine and chlorhexidine were the cleaning agents used on the device.Betadine was the solution/agent used on the insertion site prior to product placement.The issue did not lead to vessel/vein damage.The patient did not have air embolism.There was 5-10ml of blood loss because of the continuous bleeding at the puncture site, blood transfusion was not required, and no other intervention/treatment required as a result of the event.The patient was stable and had no further issues.

Manufacturer Narrative

Additional information: d9, g1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the sheath fragmented.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.

Manufacturer Narrative

Additional information: g3 correction: b5 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.

Event Description

According to the reporter, prior to procedure, flushing was done successfully.During insertion at the right femoral vein, catheter tip was not passing through the tip of the pull apart sheath, before the catheter was inserted, after repeated attempts, the pull apart sheath bent, split/cut midway (at the middle), stayed in the patient body for a few minutes.No additional surgical procedure required.Both parts were retrievable, retrieved manually with help of forceps on the same day of the event, all parts removed on same procedure, it took few minutes to remove both parts, x-ray machine performed to make sure all the pieces were retrieved, all pieces were accounted for and the x-ray was done in addition due to pull apart sheath issue.Following the pull apart sheath fault, the catheter was removed and new catheter with similar model number and same lot was used on the same day of the event, the pull apart sheath was discarded, a new sheath came from the replacement kit utilized, the new catheter was successfully inserted on the same inse rtion site, subsequently good back flow was also observed and the procedure was completed.Resistance encountered and no excessive force used when inserting the catheter tip to the pull apart sheath.There was no leak from valve of the sheath, there was no attempt to split the pull apart sheath prior to sheath break and the pull apart sheath used the one included in the kit.The dimension of the catheter and sheath matched what was indicated on the label, there was no problem with the catheter's dimension and no visual defect/damage noted on the catheter or on the catheter tip.The catheter was not repaired, no leak, tego was not utilized, there was no luer adapter issue, betadine and chlorhexidine were the cleaning agents used on the device.Betadine was the solution/agent used onthe insertion site prior to product placement.The issue did not lead to vessel/vein damage.The patient did not have air embolism.There was 5-10ml of blood loss because of the continuous bleeding at the puncture site, blood transfusion was not required, and no other intervention/treatment required as a result of the event.The patient was stable, and had no further issues.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 13580842
• MDR Text Key: 285966983
• Report Number: 3009211636-2022-00049
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013216
• UDI-Public: 10884521013216
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: 8888145018
• Device Catalogue Number: 8888145018
• Device Lot Number: 1803100119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/14/2022; 08/30/2022; 08/30/2022
• Supplement Dates FDA Received: 03/29/2022; 09/01/2022; 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention