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

Catalog Number	AB35W10040135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two cine images analysis summary: the evercross dilatation catheter was not received for evaluation.No ancillary devices from the procedure were received for evaluation.Two photographic images of cine images were provided.The first image is of the patient¿s left common femoral vein.The evercross dilatation catheter balloon is inflated within two kissing stents.A support catheter is visible in the right common femoral vein.A guidewire runs through the support catheter and evercross dilatation catheter.The second image is of the patient¿s left common femoral vein.The ancillary devices in the patient¿s right common femoral vein have been removed.An ancillary device is seen at the top of the cine image approaching from the abdominal vein.The evercross dilatation balloon chamber appears to be deflated within the kissing stents.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using an evercross balloon with a non-medtronic 8f sheath and a 0.035 non-medtronic guidewire for treatment of a 200 mm, 70% (stenosed) soft tissue clot in the patient¿s mid left common femoral vein.The vessel diameter was reported to be between 16-18 mm.A non-medtronic inflation device was used with isovue and saline 1:3.The device was prepped without issue.The device did pass through a previously deployed stent.No resistance was encountered nor excessive force used when advancing the device to the lesion.It was reported that the balloon burst at a pressure of 9 atms for 10 seconds on first inflation.The balloon fragments were retrieved with cystograspers and non medtronic catheters were placed bilaterally.No patient injury was reported.

• 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: 7577667
• Report Number: 2183870-2018-00319
• Device Sequence Number: 2629711
• Product Code: LIT
• UDI-Device Identifier: 00821684062265
• UDI-Public: 00821684062265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/07/2018

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: 11/16/2020
• Device Catalogue Number: AB35W10040135
• Device Lot Number: A558166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/07/2018
• 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: 77 YR
• Patient Weight: 96