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

Catalog Number	AB14W040210150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/30/2019
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 014 pta balloon to treat a moderately calcified, slightly tortuous plaque chronic total occlusion(cto, 100% stenosis) lesion in the right distal popliteal & superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 6mm & 350mm, respectively.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 0.014 non-medtronic guidewire were used with no embolic protection.The device was inflated with a non-medtronic inflation device and 50/50 contrast/saline solution was used as inflation fluid.The device did pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.It was reported that on the 4th or 5th inflation to 10atm, the balloon ruptured folding over on itself.A snare was used to retrieve the balloon and the procedure was continued.No patient injury was reported.

• 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: 8627166
• Report Number: 2183870-2019-00284
• Device Sequence Number: 1968076
• Product Code: LIT
• UDI-Device Identifier: 00763000110208
• UDI-Public: 00763000110208
• 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
• Report Date (Section B): 05/21/2019

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: 03/14/2022
• Device Catalogue Number: AB14W040210150
• Device Lot Number: A799525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/21/2019
• 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
• Patient Age: 76 YR