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

Catalog Number AB14W035210150

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was using a nanocross pta balloon with a non medtronic 6fr sheath and guide wire to treat a moderately calcified fibrous lesion in the left proximal posterior tibial artery with a 65% stenosis. The vessel diameter and lesion length are 2. 3mm and 80mm respectively. The vessel is little tortuous. The contract and saline was used to inflate the device. No damage noted to packaging. No issues noted when removing the device the hoop/tray. The device was prepped per ifu. It was reported that the balloon would not deflate at the lesion site. The flow was impeded in vessel. The deflation issue was noted during subsequent inflation. The balloon delivery system was deformed - stretching and twisting. Physician also experienced difficulty removing the device following the balloon inflation. The balloon was eventually deflated enough to be pulled out with the sheath. There was no resistance encountered when advancing the device and no excessive force used. There was no patient injury reported.

• 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: 9005850
• MDR Text Key: 194677725
• Report Number: 2183870-2019-00438
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132777
• 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: 12/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: AB14W035210150
• Device Lot Number: A876381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage