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

Catalog Number AB35W10040080

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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end of the most central end of the balloon, while keeping on the wire, and the entire system, including the sheath, was withdrawn over the wire.The procedure then proceeded, and the patient was treated without rupture of the vessel.No further patient injury was reported.

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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7275185
• MDR Text Key: 100235056
• Report Number: 2183870-2018-00094
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684062258
• UDI-Public: 00821684062258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention