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

Catalog Number AB14W050040150

Device Problems Entrapment of Device (1212); Fracture (1260); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a nanocross elite with a 6fr non-medtronic sheath and nitrex wire during treatment of a 150mm, calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm. Moderate vessel tortuosity and severe calcification are reported. Ifu was followed. No issues noted to packaging prior to use. No issues noted when removing he device from the packaging. The device was prepped without issue. A non-medtronic inflation device was used with heparinized saline and contrast for balloon inflation. The device was passed through a previously deployed stent without resistance. It is reported that on the second inflation when the balloon was inflated to 14atm, the device became caught on a stent. Resistance was encountered during withdrawal and excessive force was used. The balloon is reported to have fractured. A snare was used to remove the detached balloon fragment from the patient. No patient injury reported.

Manufacturer Narrative

Additional information: the device passed through a previously deployed 6x150 everflex stent without resistance. There were no issues caused to the stent. No further patient injury was reported for this event. If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS ELITE 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: 9502624
• MDR Text Key: 172441896
• Report Number: 2183870-2019-00597
• 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: 03/09/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/20/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: AB14W050040150
• Device LOT Number: A839903
• 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: 03/06/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/31/2019
• 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: 12/20/2019 Patient Sequence Number: 1