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

Model Number	AB14W020100150
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: the customer sent one image.The image shows twisting to the proximal end of the balloon.Product analysis: the device returned loosely coiled inside a shelf carton and inside two biohazard bags.Lot number on shelf carton label: b221202.The device was decontaminated with cidex opa solution soak.A visual inspection of the device found a twist on the proximal end of the balloon.A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.A 0.014¿ guidewire was loaded through the tip and exited the hub without any difficulty.An indeflator with pressure gauge was used to inflate the balloon to 8 atm and 14 atm but the balloon would not inflate.There was evidence of hardened contrast in the shaft of the device, and this is the most likely reason that the balloon will not inflate.The device was left in warm water overnight in an attempt to soften the contrast, but this was unsuccessful.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a nanocross elite pta balloon with a 6fr non-medtronic sheath and a 0.014 non-medtronic guidewire during treatment of a 120mm fibrous lesion in the patient¿s mid anterior tibial artery.Little vessel tortuosity and little calcification are reported.Artery diameter reported as 2mm.No embolic protection was used.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.A non-medtronic inflation device was used.50/50 inflation fluid was used.The balloon was not passed through a previously deployed stent.No resistance was noted during advancement of the device.It is reported balloon inflation difficulties occurred at an inflation pressure of 8atm.Balloon just did not inflate properly, very proximal and very small portion of the balloon inflated and the rest of the balloon did not.There was no leaks noted.No intervention was required to remove the device.The device was safely removed from the patient.A new balloon was used to complete the procedure.No patient injury reported.A twist was noted on the proximal end of the returned balloon.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• MDR Report Key: 12751579
• Report Number: 2183870-2021-00400
• Device Sequence Number: 13816730
• Product Code: LIT
• UDI-Device Identifier: 00763000109509
• UDI-Public: 00763000109509
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 06/14/2024
• Device Model Number: AB14W020100150
• Device Catalogue Number: AB14W020100150
• Device Lot Number: B221202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1