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

Catalog Number	AB14W030150150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
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 was attempting to use a nanocross pta balloon dilatation catheter to treat a severely calcified 100mm cto (chronic total occlusion-100%) in the left mid-distal anterior tibial artery.The artery had a diameter of 3mm and had little tortuosity.The procedure used a 7 fr non-medtronic 45 cm sheath and a 0.014" 300 cm non-medtronic guidewire.The balloon was inflated using a medtronic inflation device with 50/50 contrast hep/ saline fluid, as per the ifu.The device was prepped as per the ifu with no issues identified.The vessel was not pre-dilated.No resistance was encountered when advancing the device and the device did not pass through a previously deployed stent.No excessive force was used.It was reported that during the first inflation at 8 atm, the balloon burst occurred.The balloon was removed by withdrawing over the wire under fluoroscopy.The procedure was completed using a non-medtronic balloon.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: 7089989
• Report Number: 2183870-2017-00546
• Device Sequence Number: 1895388
• Product Code: LIT
• UDI-Device Identifier: 00821684066508
• UDI-Public: 00821684066508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/06/2017

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: 02/15/2019
• Device Catalogue Number: AB14W030150150
• Device Lot Number: A228199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 88