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

Model Number AB14W050200150

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

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a nanocross elite pta balloon during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa). Severe vessel calcification is reported. There was no damage noted when removing the device from the product packaging. No issues were noted when removing the device from the hoop/tray. Ifu was followed and the device was prepped without issue. The device was not passed through a previously deployed stent. No resistance was noted during advancement. Removal difficulties are reported. It is reported after inflation of the balloon to 10atm for 2 minutes, the balloon was repositioned and again inflated to 10atm. The balloon is reported to have ruptured with the balloon shaft stripping off the balloon. On attempt to remove the device, a section of the balloon separated from the catheter. Antegrade access was gained and a snare was used to retrieve the balloon in the popliteal. The patient is reported to be fine without any reported issues. No further injury re ported.

• 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: 10790980
• MDR Text Key: 214752841
• Report Number: 2183870-2020-00360
• 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
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB14W050200150
• Device Catalogue Number: AB14W050200150
• Device Lot Number: B061991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/30/2020
• 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: 11/05/2020 Patient Sequence Number: 1