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

Model Number	AB35W07040135
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use an evercross pta balloon with a 6fr sheath and 0.035 non-medtronic guidewire during treatment of a 30mm fistulogram in the patient¿s mid right cephalic vein.Slight vessel tortuosity is reported.Vessel diameter reported as 7mm.Lesion exhibited 50% stenosis.No damage was noted to the device packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.A non-medtronic inflation device was used with a 25% contrast: 75% saline mix.The device was not passed through a previously deployed stent.No resistance was noted during advancement of the device.It is reported a circumferential/radial balloon burst occurred at an inflation pressure of 13atm.One prior inflation had been applied to the device.It is reported during removal the balloon became stuck and a part of the balloon and tip of the catheter broke off and became stuck where the cephalic vein bifurcates into the cephalic imbecilic.A tourniquet was applied to the upper arm and an open incision was made to remove the piece a balloon and catheter.The patient is reported to be doing well and no other injury was reported.
Additional Manufacturer Narrative
Additional information: all components of the device were removed.There was no damage to the treated area of the vessel and no additional treatment was given to the patient.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
Device evaluation the evercross catheter was received in four segments: proximal segment including the y-manifold and proximal balloon bond, a long inner guidewire lumen segment with two radiopaque marker bands, a short distal segment that included distal tip and distal balloon bond, and balloon chamber material segment.The balloon chamber material segment exhibited both radial and longitudinal tearing.All components of the 7mm by 40mm balloon were accounted for.Per the initial reported event description, ¿all components of the device were removed¿.Technical analysis of the returned evercross dilatation catheter confirmed the reported event of radial balloon burst at 13atm, (rated burst pressure 14atm), resulting in withdrawal difficulties that cause catheter separation requiring surgical intervention to remove the separated pieces of the catheter.The root cause could not be positively determined.The most likely root cause would be procedural/anatomy related.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: 10481548
• Report Number: 2183870-2020-00276
• Device Sequence Number: 11785449
• Product Code: LIT
• UDI-Device Identifier: 00763000184599
• UDI-Public: 00763000184599
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: AB35W07040135
• Device Catalogue Number: AB35W07040135
• Device Lot Number: B042689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/26/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/03/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR