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

Catalog Number	AB14W020210150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported during inflation of a nanocross pta balloon catheter, the balloon burst and the procedure could not be continued.Lesion morphology is unknown.The balloon was inflated once prior to the burst.Burst pressure and the type of burst were not reported.It is unknown if there were any fragments of the balloon.It was reported that the procedure was completed with this device and no patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the nanocross balloon dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.The nanocross dilatation catheter was received with sanguine residue within the inflation portion of the y-manifold, sanguine residue/fluid within the balloon chamber, and the balloon chamber in a post-inflation profile.Attempts were made to inflate the balloon without a guidewire as a guidewire could not pass through the guidewire lumen.The balloon chamber started to inflate at approximately 4 atm (nominal pressure = 8 atm rated burst pressure = 14 atm).However, at this point a pinhole leak was noted in the proximal end of the balloon chamber.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: 7291059
• Report Number: 2183870-2018-00113
• Device Sequence Number: 2248458
• Product Code: LIT
• UDI-Device Identifier: 00821684066201
• UDI-Public: 00821684066201
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2020
• Device Catalogue Number: AB14W020210150
• Device Lot Number: A461820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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