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

Model Number AB14W060200150

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2022

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 nanocross elite pta balloon catheter during procedure to treat a none calcified fibrous lesion in the proximal superficial femoral artery (sfa) with 90% stenosis. The vessel was little tortuous. A non-medtronic inflation device was used for balloon inflation. There was no damage noted to packaging. There was no issue noted when removing the device from hoop/tray. The device was prepped per ifu with no issues identified. It was reported that balloon deflation difficulties occurred. The device was slow to deflate at the lesion site with a deflation time of 8 minutes. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. A 60cc syringe was used to deflate the balloon. There was no patient injury reported.

• Brand Name: NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13857323
• MDR Text Key: 292979400
• Report Number: 2183870-2022-00092
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110529
• UDI-Public: 00763000110529
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB14W060200150
• Device Catalogue Number: AB14W060200150
• Device Lot Number: B327787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/25/2022
• 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: 03/23/2022 Patient Sequence Number: 1