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

Catalog Number	AB14W035080150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was using a nanocross pta balloon to treat a lesion in the mid right popliteal artery.The lesion was described as severely calcified, with slight tortuousity and about 7cm in length in a vessel described as approx.3.5-4mm in diameter.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 6fr non-medtronic sheath and a 0.014 non-medtronic guidewire were used with no embolic protection.It was reported that during the second inflation of the balloon to 10atm, the balloon burst.Most fragments of the balloon were retrieved by snare and one fragment was caged with a stent.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: a non-medtronic stent which had to be deployed in an unintended area was used to cage the balloon fragments to the vessel wall.If information is provided in the future, a supplemental report will be issued.
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: 8771315
• Report Number: 2183870-2019-00363
• Device Sequence Number: 2296491
• Product Code: LIT
• UDI-Device Identifier: 00763000109967
• UDI-Public: 00763000109967
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• 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,Followup
• Report Date (Section B): 10/04/2019

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: 05/19/2022
• Device Catalogue Number: AB14W035080150
• Device Lot Number: A834198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 10/03/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/10/2019; 10/04/2019
• 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