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

Catalog Number	AB14W030150150
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Fragmentation (1261)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6428972
• Report Number: 2183870-2017-00140
• Device Sequence Number: 16152343
• Product Code: LIT
• UDI-Device Identifier: 00821684066508
• UDI-Public: 00821684066508
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2019
• Device Catalogue Number: AB14W030150150
• Device Lot Number: A218242
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention