MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	AB35W06200135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a venaseal kit during patient treatment.Ifu was followed.It is reported during preparation of the delivery catheter the gun malfunctioned and would not advance.The physician troubleshooted the issue and completed the case by manually delivering adhesive by pushing the plunger.No patient injury reported.Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).The device is reported to have been defective, but the procedure was completed using this device.The vein is reported to have closed.No patient injury reported.Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).It is reported the gun would not engage and adhesive could not be dispensed.The physician pushed on the back of the plunger so the teeth would engage to complete the procedure using this device.The vein is reported to have closed.No patient injury reported.Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).It is reported the gun would not engage and adhesive could not be dispensed.The physician was able to complete the procedure using this device.The vein is reported to have closed.No patient injury reported.Physician used a venaseal kit during treatment of the patient¿s bilateral great saphenous vein (gsv) the physician gained access to the vein, primed the delivery catheter and treated the right gsv as per the ifu without any issues and glue was present the entire length treated.After completing the treatment of the right gsv the physician gained access to the left gsv, primed the delivery catheter and began his treatment as per the ifu.The physician successfully delivered the 1st and 2nd aliquot and the sonographer held compression at the junction for 3 minutes.The physician continued with treatment as per the ifu.During the 5th aliquot delivery, it was noticed that the plunger was not advancing forward.The physician was still using the 1st syringe of glue, but there was only a little bit of glue left in the syringe.The physician disengaged the syringe from the gun as per the ifu the other syringe could be used to use the remaining glue.When the physician pulled the trigger to get the plunger to meet with the back of the syringe, it would not advance glue.The physician applied pressure to the back of the gun which allowed the plunger to engage and advance glue forward allowing him to complete the procedure.The sonographer checked the vein after the procedure, the vein was closed, and glue was present the entire length of treatment.5cm from sfj to proximal calf was treated.Total length of treatment was 31cm.The vein is reported to have closed.No patient injury reported.Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).It is reported the gun failed to deliver adhesive halfway into the procedure despite multiple pulls of the trigger.The gun was reset (removing the syringe and advance the plunger fully forward and fully back) to fix this issue.The procedure was completed using this kit.The vein is reported to have closed.No patient injury reported.Physician intended to use a venaseal kit during patient treatment.Ifu was followed.Prior to use a gun failure is reported.This issue is reported for 2 kits.A third kit was used to carry out treatment.No patient involvement.Physician intended to use a closurefast catheter with an rfg3 during treatment of the great saphenous vein (gsv).It was reported that the generator displayed ¿device is broken¿ when the catheter was connected.A second catheter was opened and used with the same rfg3 to complete the procedure without issue.No patient injury reported.Physician intended to use a closurefast catheter during patient treatment.It was reported that the device was faulty.No patient injury reported.Frmeventdataview eventid (b)(6) physician intended to use a venaseal kit during patient treatment.Ifu was followed.It is reported the gun would not work.A second kit was used to carry out treatment.No patient involvement.Physician intended to use a venaseal kit during patient treatment.Ifu was followed.It is reported the physician pulled the trigger on the glue gun, but the gun did not dispense glue.The physician had to disconnect the catheter from the gun and put glue in by using the syringe.No patient injury reported.Physician intended to use a venaseal kit during patient treatment.Ifu was followed.It is reported the gun was not working correctly and was not pushing glue forward.This kit was used to complete the procedure.No patient injury reported.As this kit was used for treatment please provide the following information: patient demographics (age, gender, dob)? did the vein close? physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).It is reported the was not ad vancing glue properly.The procedure was completed successfully with this kit by a using more exaggerated flick on release after each squeeze of the trigger.No patient injury reported.Physician intended to use a venaseal kit during patient treatment.Ifu was followed.Prior to use it is reported the dispenser gun would not engage syringe plunger to extrude glue for closure procedure.This issue is reported for 4 kits.A replacement kit was used to carry out treatment.No patient involvement.Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).It is reported the trigger on the gun failed during the priming process.The physician opted to manually inject adhesive.The procedure was completed using this kit.73cm of vein was treated.The vein is reported to have closed.No patient injury reported.Physician intended to use an evercross pta balloon with a 5fr/6fr sheath and 2 non-medtronic 0.035 guidewires during treatment of a 250mm calcified cto (chronic total occlusion-100%) in the patient¿s mid left superficial femoral artery (sfa).Severe vessel calcification and tortuosity is reported.Artery diameter reported as 6mm.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at nominal pressure (8atm).No balloon fragments remained in the patient.A second evercross pta balloon was opened and prepped without issue.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at 10atm.No balloon fragments remained in the patient.A non-m edtronic balloon was used.The physician then opened a third evercross pta balloon and intended to use it with a 6fr/7fr sheath and non-medtronic guidewire.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at nominal pressure.The device as removed from the patient and a fourth evercross pta balloon was used.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at rated burst pressure.Finally, a non-medtronic balloon was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: it was confirmed that a burst occurred in 3 balloons.The balloons were safely removed from the patient without intervention.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.
Additional Manufacturer Narrative
Correction to b5: physician intended to use an evercross pta balloon with a 5fr/6fr sheath and 2 non-medtronic 0.035 guidewires during treatment of a 250mm calcified cto (chronic total occlusion-100%) in the patient¿s mid left superficial femoral artery (sfa).Severe vessel calcification and tortuosity is reported.Artery diameter reported as 6mm.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at nominal pressure (8atm).No balloon fragments remained in the patient.A second evercross pta balloon was opened and prepped without issue.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at 10atm.No balloon fragments remained in the patient.A non-m edtronic balloon was used.The physician then opened a third evercross pta balloon and intended to use it with a 6fr/7fr sheath and non-medtronic guidewire.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at nominal pressure.The device as removed from the patient and a fourth evercross pta balloon was used.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.A non-medtronic inflation device was used for balloon inflation.The device was passed through a previously deployed stent and resistance was noted.A circumferential balloon burst is reported at rated burst pressure.Finally, a non-medtronic balloon was used to complete the procedure.No patient injury reported.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.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11108072
• Report Number: 2183870-2021-00004
• Device Sequence Number: 3698072
• Product Code: LIT
• UDI-Device Identifier: 00763000184513
• UDI-Public: 00763000184513
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: AB35W06200135
• Device Catalogue Number: AB35W06200135
• Device Lot Number: B104135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 02/12/2021; 04/14/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/04/2021; 02/23/2021; 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR