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

Catalog Number	AB14W050120150
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Date of Event	02/01/2019
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 intended to use a 5x120x150 nanocross elite pta balloon to treat a slightly calcified slightly tortuous lesion in the proximal superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 5mm & 20mm, 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.No embolic protection was used.The device was inflated with a non-medtronic inflation device.The device did pass through a previously deployed stent and no resistance was encountered on advancing the device to the target lesion.There were wire movement issues reported and the guidewire locked up during the procedure.The nanocross elite pta balloon was reported to have ruptured during inflation at 14atm.The procedure was completed using a sheath and the balloon was removed.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received a non-medtronic guidewire and sheath were used during the procedure.Patient had surgery to retrieve the balloon fragments from the common femoral artery.If information is provided in the future, a supplemental report will be issued.

• 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: 8330440
• Report Number: 2183870-2019-00068
• Device Sequence Number: 1663730
• Product Code: LIT
• UDI-Device Identifier: 00821684066966
• UDI-Public: 00821684066966
• 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,Followup,Followup
• Report Date (Section B): 05/01/2019

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: 10/09/2021
• Device Catalogue Number: AB14W050120150
• Device Lot Number: A721353
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/19/2019; 04/29/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/13/2019; 05/01/2019
• 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: 65 YR
• Patient Weight: 102