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

Catalog Number	AB14W025210150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the nanocross elite was returned for analysis.The catheter was inspected and noted buckling of the balloon material approximately 18.5 through to 20.5 cm from the distal tip.Under microscope, buckling of the blue inner assembly was noted approximately 7 cm from the distal tip.The working length was approximately 150 cm.A 0.014" guidewire from the lab was unable to be loaded due to the damaged inner assembly.The nanocross elite balloon port on the manifold was connected to an inflation device in the lab.Approximately 12 atm of water pressure was applied and the balloon inflated with no indication of a leak.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a nanocross elite pta balloon to treat a severely calcified and moderately tortuous proximal common iliac artery lesion exhibiting chronic total occlusion.The device was removed from its packaging and inspected with no issues noted.The device was prepped per the ifu.The device did not pass through a previously deployed stent.Resistance was not encountered and no excessive force was used.The balloon was inflated using a non-medtronic inflation device and a 50/50 contrast saline mix.The balloon was used to inflate the subintimal space of the common iliac / aorta.No issues were noted inflating or deflating the balloon.The physician experienced removal difficulties.The balloon was flushed in an attempt to lubricate the balloon with no success.The balloon did not catch on the sheath during removal.The physician was able to forcefully remove the balloon and the wire placement was not lost.No patient injury was reported.

• 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: 6975138
• Report Number: 2183870-2017-00463
• Device Sequence Number: 16305862
• Product Code: LIT
• UDI-Device Identifier: 00821684066362
• UDI-Public: 00821684066362
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/24/2017

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: 03/18/2019
• Device Catalogue Number: AB14W025210150
• Device Lot Number: A246226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR