MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB14W035080150

Device Problem Burst Container or Vessel (1074)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/05/2019

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 a nanocross pta balloon to treat a lesion in the mid right popliteal artery. The lesion was described as severely calcified, with slight tortuousity and about 7cm in length in a vessel described as approx. 3. 5-4mm in diameter. 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 6fr non-medtronic sheath and a 0. 014 non-medtronic guidewire were used with no embolic protection. It was reported that during the second inflation of the balloon to 10atm, the balloon burst. Most fragments of the balloon were retrieved by snare and one fragment was caged with a stent. No patient injury was reported.

Manufacturer Narrative

Additional information: a non-medtronic stent which had to be deployed in an unintended area was used to cage the balloon fragments to the vessel wall. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• 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: 8771315
• MDR Text Key: 150403717
• Report Number: 2183870-2019-00363
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082854
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/19/2022
• Device Catalogue Number: AB14W035080150
• Device Lot Number: A834198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/20/2019
• 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: 07/09/2019 Patient Sequence Number: 1