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

Catalog Number AB35W10040080

Device Problem Burst Container or Vessel (1074)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using an evercross pta balloon to treat a moderately calcified, moderately tortuous, fibrous lesion in the mid right subclavian artery. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was prepped without issue. A 7fr non-medtronic sheath was used with no embolic protection. The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion. The device was inflated to 8atm using an inflation device and a mix of saline/contrast as inflation fluid. It was reported that the balloon burst on the first inflation and fragmented. Part of the balloon remained in the patients artery so, an 8x80x80 stent was used to cage it against the vessel wall. A new balloon was used to successfully complete the procedure. No patient injury was reported.

Manufacturer Narrative

The everflex se stent was used successfully to cage the device component against the vessel wall. The procedure was completed with no further issues. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation. The catheter was received with the balloon chamber fractured from the distal tip. Visual inspection of the balloon showed a radial burst with the catheter fractured off within the balloon segment. Blood residue was observed within the fractured balloon chamber. Approximately 3. 5cm of the balloon remained on the catheter. The working length of the catheter was approximately 78. 5cm. The product label specification shows the working length is 80cm. Visual inspection under magnification of the distal edge of the catheter shows the inner guidewire lumen is separated at the distal edge of the proximal radiopaque marker band. The proximal marker band exhibits evidence of been tensely pull distal from its original position. It should be noted the distal portion of the evercrosss device which fractured off within the vessel was not returned for investigation. 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: 8748332
• MDR Text Key: 149644576
• Report Number: 2183870-2019-00353
• Device Sequence Number: 1
• Product Code: LIT
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2022
• Device Catalogue Number: AB35W10040080
• Device Lot Number: A840672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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: 07/01/2019 Patient Sequence Number: 1