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

Catalog Number AB14W030150150

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

During an attempt to treat the posterior tibial artery (pta) reported to be severely calcified with little tortuosity using nanocross elite balloon catheter, it was reported that the nanocross elite balloon ruptured on first inflation.After the balloon ruptured the physician could not get the balloon back out of the vessel.The balloon then detached from the balloon catheter.Physician made numerous attempts to snare and remove the balloon.Remaining portion of the balloon catheter was removed and the sheaths were removed.The physician was not able to retrieve the balloon and remains in the patient.No further clinical sequelae reported for this event.

Manufacturer Narrative

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

• Brand Name: NANOCROSS 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: 6428972
• MDR Text Key: 70698646
• Report Number: 2183870-2017-00140
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684066508
• UDI-Public: 00821684066508
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2019
• Device Catalogue Number: AB14W030150150
• Device Lot Number: A218242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Date Device Manufactured: 01/27/2016
• 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
• Patient Outcome(s): Required Intervention