MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, PERCUTANEOUS

Model Number AB14W030150150

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2013

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien plymouth location, fo llowing medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).

Event Description

The physician was attempting to treat the right leg btk.It is reported that the balloon would not reach nominal pressure, staff noticed blood feedback, and realized that the balloon had burst before reaching nominal pressure.Balloon was pulled out in one unit.Nothing was left in the patient.Evaluation summary: the nanocross catheter was received for evaluation without any ancillary devices or cine images from the procedure.The balloon chamber had visible signs of being in a post inflated state and exhibited blood residue in the chamber.A water-filled syringe was attached to the inflation port and the balloon chamber and the system was pressurized to locate the leak in the catheter.A pinhole leak was located 70-mm from the proximal band marker.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN ; 7633987000
• MDR Report Key: 5322104
• MDR Text Key: 34928079
• Report Number: 2183870-2015-07613
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2014
• Device Model Number: AB14W030150150
• Device Catalogue Number: AB14W030150150
• Device Lot Number: 9533412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1