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

Model Number AB14W020100150

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

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 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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12751579
• MDR Text Key: 280120801
• Report Number: 2183870-2021-00400
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000109509
• UDI-Public: 00763000109509
• Combination Product (y/n): N
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1