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

Model Number	AB14W060080150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
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
Physician was attempting to use a nanocross pta balloon catheter along with a non-medtronic 6fr sheath and nitrex 0.014" guide wire during procedure to treat a moderately calcified plaque lesion in the left mid superficial femoral artery (sfa) with 80% stenosis.The vessel diameter and lesion length are 6mm and 60mm respectively.A non-medtronic inflation device was used to inflate the balloon.There was no damage to device packaging.There was no issue noted while removing device from hoop/tray.The device was prepped per ifu with no issues identified.During second balloon inflation a circumferential/radial burst occurred at 12 atm.All balloon fragments were retrieved.The device passed through a previously deployed stent.No resistance occurred while advancing device.It was reported that physician was post dilating a stent when the balloon ruptured.The balloon was then removed with all pieces attached.A second nanocross balloon was used to finish dilating the stent.No patient injury or other issues happened during the procedure.

• Brand Name: NANOCROSS ELITE 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: 10487260
• Report Number: 2183870-2020-00281
• Device Sequence Number: 2552988
• Product Code: LIT
• UDI-Device Identifier: 00763000110444
• UDI-Public: 00763000110444
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/03/2020

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: 08/01/2023
• Device Model Number: AB14W060080150
• Device Catalogue Number: AB14W060080150
• Device Lot Number: B063262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 109