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

Catalog Number	AB14W060100150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the nanocross elite dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.The nanocross elite balloon chamber was received in a post-inflation profile with fluid in the balloon chamber.Stretching could be seen on the inner guidewire lumen within the balloon chamber.Examination of the proximal balloon bond revealed a crimp of the outer shaft of the inflation lumen.A 0.035¿ guidewire was loaded through, both, the distal tip and the y-manifold proximal hub ¿ it would only advance to the area of the balloon chamber where the guidewire lumen was stretched.The balloon chamber was inflated to nominal pressure of 8atm.The dilatation catheter was then inflated to rated burst pressure of 14atm.The dilatation catheter was able to hold nominal and rated burst pressures.A vacuum was pulled, and the balloon chamber would not fully deflate at either one minute or 90 seconds.The nanocross elite dilatation catheter exhibited a narrowing of the distal edge of the inflation lumen.This narrowing of the inflation pathway would have occurred during manufacturing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a nanocross elite balloon with a 6fr non-medtronic guidewire to treat a moderately calcified lesion with a moderate degree of tortuosity in the proximal superficial femoral artery (sfa).The artery diameter was reported as 6mm with a lesion length of 100m.The balloon was reported to have been inflated using a non-medtronic inflation device.The ifu was followed and the device was prepped without issue.It was reported that once the device was inflated it would not deflate at the lesion site and had difficulty being removed from the patient.The force of pulling it through the sheath helped it to deflate and be removed.The balloon did not deflate fully at any point.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: 7922570
• Report Number: 2183870-2018-00450
• Device Sequence Number: 19284473
• Product Code: LIT
• UDI-Device Identifier: 00821684067109
• UDI-Public: 00821684067109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/01/2018

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: 11/15/2020
• Device Catalogue Number: AB14W060100150
• Device Lot Number: A557241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1