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

Model Number AB14W025150150

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a nanocross pta balloon during procedure to treat a severely calcified lesion in the mid anterior tibial artery (ata). The vessel was little tortuous. A non-medtronic inflation device used to inflate the balloon. There was no damage noted to packaging. There are no issues noted when removing device from hoop/tray. The device was prepped per ifu with no issues noted. It was reported that during balloon inflation, balloon burst/leak/rupture occurred at 8atm. All balloon fragments were not retrieved. A stent was implanted in the tibial artery to cage in the balloon fragments and maximize the lumen. No further patient injury.

• 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 ; EI ; 091708734
• MDR Report Key: 11170492
• MDR Text Key: 226809840
• Report Number: 2183870-2021-00023
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/14/2021
• Device Model Number: AB14W025150150
• Device Catalogue Number: AB14W025150150
• Device Lot Number: A675828
• 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: 02/11/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/14/2021 Patient Sequence Number: 1