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

Catalog Number AB35W06040080

Device Problem Burst Container or Vessel (1074)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/04/2017

Event Type  Injury  

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. The evercross dilatation catheter was received in two segments: the proximal segment including the y-manifold and catheter down to the proximal balloon bond, and the distal inner guidewire lumen with radiopaque markers, balloon chamber material, and distal tip. All components of the evercross dilatation catheter were accounted for. The separation face of the proximal segment includes the balloon chamber proximal bond to the catheter. The catheter exhibits a small amount of necking down and tensile stretching. The small segment of balloon material exhibits radial tearing. Approximately 10cm of distal inner guidewire lumen with two radiopaque marker bands, balloon chamber material, and distal tip were received loose within the open labelled pouch. The distal segment was placed in a tub of water to clean and relax the material to allow examination of the balloon chamber material. The proximal end of the distal segment exhibits tensile stretching proximal to the proximal radiopaque marker band. This proximal section exhibits lateral compression most likely from the retrieval process. The distal section material between the two radiopaque marker bands exhibit zones of tensile stretching and lateral compression. The balloon material was able to be unfolded and measured. The balloon material exhibits longitudinal and radial tearing. All of the 6mm by 40mm balloon materials appears to be accounted for. The distal inner guidewire lumen exhibits tensile stretching that has elongated the distance between the two radiopaque markers to approximately 65mm. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Ancillary devices used during the procedure: non-medtronic 5 fr sheath non-medtronic 0. 035 guidewire non-medtronic inflation device additional information: patient developed mild stenosis at the site of surgical closure. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.

Event Description

Physician used an evercross pta balloon device for a fistuloplasty procedure of the arm. Ifu was followed. An inflation device was used for inflation. It was reported that the balloon burst during inflation at a pressure of 11atms. It was reported that the physician tried to remove the balloon, and it sheared off on sheath and snapped. The balloon remained in the vessel. Physician had to perform a cut down to retrieve the balloon fragments. It was reported that vessel injury occurred.

• 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: 6758714
• MDR Text Key: 100526897
• Report Number: 2183870-2017-00323
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/26/2019
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A217943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/01/2017 Patient Sequence Number: 1