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

Model Number AB14W020020150

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It is reported that the balloon would not cross the lesion.The physician removed the balloon and ran the guidewire to a second lesion.The balloon was reinserted and inflated to approximately 2- 3 atms when a slow blush of contrast was seen in the middle of the balloon and pressure was lost in the inflation device.It was safely removed intact and a new balloon was used to finish treating area.No patient injury is reported.Evaluation summary: the returned nanocross device was received without any ancillary devices or cine images from the procedure.The catheter lumen and balloon chamber exhibited blood residue in the chamber indicating fluid communication with a sanguine environment.The balloon appeared to be intact and in a post-deflated state.A water filled syringe was added to the balloon port to inflate the balloon.No leaks were observed in either the lumen or balloon chamber.The balloon chamber remained inflated during microscopic inspection.

• 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 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5322039
• MDR Text Key: 35012749
• Report Number: 2183870-2015-07609
• 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: 05/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: AB14W020020150
• Device Catalogue Number: AB14W020020150
• Device Lot Number: 9543814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2013
• Initial Date FDA Received: 12/23/2015
• Date Device Manufactured: 02/06/2012
• 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