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

Catalog Number	AB14W030040150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection: the nanocross elite model ab14w030040150 was inspected.The distal end of the catheter was inspected under micros cope.No damages were noted to the distal tip of the catheter; however, the balloon section distal the distal marker band showed signs of a previous insertion according to the shape of the balloon.Functional testing: a 0.014" guidewire from the lab was front loaded with no resistance (photo 7).The inflation device filled with water in the lab was connected to the balloon port of the nanocross elite manifold.Immediately after pressure was applied, the distal end of the balloon was leaking.The leaking occurred approximately 0.7cm from the distal tip (photo 9).Under microscope a longitudinal tear to the balloon was identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was intending to use a nanocross to treat a 40mm calcified lesion with 70-80% stenosis in the left mid posterior tibial artery.Vessesl diameter was 3-4mm with little tortuosity.A cook 6-90 ansel sheath and a nitrex 0.14 300cm guidewire was used in the procedure.No embolic protection was used.There was no damage to the device packaging and no issues removing the device from its packaging.The device was prepped as per ifu with no issues.The device did not pass through a previously deployed stent.No resistance was encountered and excessive force was not used.The guidewire was advanced stiff end first but it was reported that ancillary device interaction was encountered with the guidewire and nanocross, the wire exited the catheter just proximal to the balloon.Another device was used in the procedure after the guidewire was repositioned.This device was prepped with no issues.This device did not pass through a previously deployed stent.No resistance was encountered and excessive force was not used.It was reported that the balloon was inflated twice using a boston scientific inflation device with 60/40 hep sal/contrast.The balloon burst on first i nflation.The device was removed intact and an angiogram confirmed that the result was satisfactory.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: 8811919
• Report Number: 2183870-2019-00378
• Device Sequence Number: 14117714
• Product Code: LIT
• UDI-Device Identifier: 00821684066409
• UDI-Public: 00821684066409
• 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): 07/22/2019

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: 09/30/2021
• Device Catalogue Number: AB14W030040150
• Device Lot Number: A716310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 86