MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	AB14W040150150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use a nanocross balloon 014 with a non-medtronic 6 fr sheath and a non-medtronic inflation device to treat a fibrous lesion, moderately calcified with cto (chronic total occlusion-100%) in the right distal superficial femoral artery (sfa).Artery length and diameter were 40 mm and 6 mm, respectively.The device was prepped as per the ifu and no issues were noted.The physician experienced resistance upon advancing with the device through the lesion, but no excessive force was used.The device passed through a previous deployed stent.A balloon burst (rupture) was reported during inflation at 6 atm.All fragments of the balloon were retrieved.The physician attempted to use a second balloon, a nanocross elite 6 x 20 x 150 and the same issue occurred, the balloon ruptured during inflation at 6 atm using the same inflation device.The procedure was completed using a 6 x 40 pacific plus cross and then a 6 x 20 fortex balloon.No patient injury was reported.
Additional Manufacturer Narrative
Additional information reported that the balloon burst was longitudinal, the balloon came out as one piece and no fragment came off.No allegation for any other product image review: the images are of the patient¿s right superficial femoral artery.In all four images a guidewire is visible in the artery.The first and second images are of the targeted vessel prior to treatment.The second image is an enlargement of the first image.The third image is of a stent implanted in the targeted vessel.From the distal end of the stent the third, fourth, and fifth stent cell rows are not fully dilated, they appear to be constrained by a calcified concentric lesion.The fourth image is of the stent after pta dilatation.In none of the cine images is a pta balloon.The cine images do not provide confirmation of either nanocross elite balloon burst.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8221517
• Report Number: 2183870-2019-00006
• Device Sequence Number: 16561710
• Product Code: DQY
• UDI-Device Identifier: 00821684066829
• UDI-Public: 00821684066829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• 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,Followup
• Report Date (Section B): 02/26/2019

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: 10/06/2021
• Device Catalogue Number: AB14W040150150
• Device Lot Number: A719753
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 57