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

Catalog Number	AB35W10040080
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/12/2017
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
The physician was attempting to use an evercross pta balloon during an upper extremity fistulogram.The physician first dilated the balloon to nominal pressure with lack of resolution of the stenosis.It was reported the balloon was then dilated to less than burst-pressure and the balloon ruptured in the midline in a transverse manner (not along the long axis of the balloon).There were 2 free ends of the balloon still located on the treatment wire.The balloon could not be removed through the sheath.A snare catheter was advanced to the end of the most central end of the balloon, while keeping on the wire, and the entire system, including the sheath, was withdrawn over the wire.The procedure then proceeded, and the patient was treated without rupture of the vessel.No further patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the evercross dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.The evercross dilatation catheter was received in two segments.The manifold-catheter-proximal balloon chamber segment was approximately 74.8cm in length from the distal tip of the manifold strain relief.The proximal balloon chamber material exhibited both longitudinal and radial tearing.The proximal balloon marker band was present.The guidewire lumen separation was at the distal end of the marker band.The inner guidewire lumen from the balloon chamber was approximately 8.3cm in length and included the balloon¿s distal marker band.The guidewire lumen exhibited tension stretching and necking.The distal marker band exhibited lateral compression.All components of the device were accounted for.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: 7275185
• Report Number: 2183870-2018-00094
• Device Sequence Number: 1176862
• Product Code: LIT
• UDI-Device Identifier: 00821684062258
• UDI-Public: 00821684062258
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 08/17/2020
• Device Catalogue Number: AB35W10040080
• Device Lot Number: A510798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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