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

Catalog Number	AB35W06120080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the evercross dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation however, seven pages of the procedural report were also received.The evercross dilatation catheter was received in two segments.The proximal segment includes the proximal balloon bond and the majority of the balloon chamber.The distal segment includes the distal tip, distal balloon bond with balloon chamber material, and inner guidewire lumen which includes both radiopaque marker bands.All components of the evercross dilatation catheter were received.The inner guidewire lumen was observed to have been stretched to an overall length of approximately 20cm.The proximal segment includes approximately 9cm of balloon material.The balloon chamber material exhibits radial tearing.Page two of the procedure report includes the peel-off label for the evercross 6mm x 120mm dilatation catheter used.Page five of the procedure report indicates that the catheter was inserted at 11:06:08.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use an evercross with a non-medtronic 5fr sheath and a non-medtronic 0.035¿ glidewire to treat a severely calcified lesion with 80% stenosis in the distal right mid proximal iliac artery.The artery diameter and lesion length were 8mm and 90mm respectively.A non-medtronic inflation device was used.The ifu was followed and the device was prepped without issue.It was reported that a balloon fracture/rupture occurred during inflation.A pressure of 8 atm's was applied to the balloon prior to the rupture.While attempting to remove the balloon, it became caught on the calcified plaque.Additional force was needed to remove it through sheath and the shaft broke.The physician was able to remove the 5fr sheath, with the wire remaining in the patient, and the remaining portion of the catheter/balloon over the wire.No portions of the catheter/balloon remained in the patient.A 6fr sheath was then placed.No patient injury 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: 7929327
• Report Number: 2183870-2018-00453
• Device Sequence Number: 19348884
• Product Code: LIT
• UDI-Device Identifier: 00821684061718
• UDI-Public: 00821684061718
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/03/2018

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: 12/06/2020
• Device Catalogue Number: AB35W06120080
• Device Lot Number: A566629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 79