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

Model Number	AB14W060150150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A nanocross elite balloon was used to perform a balloon angioplasty procedure of a calcified lesion in the superficial femoral artery (sfa).It was reported that physician encountered difficulty in deflating the balloon and removing it.It was reported the balloon was pinched just distal to the mid-marker, and it became twisted.There was difficulty in un-wrapping the balloon.It took several minutes and several syringes to make the balloon deflate.Physician eventually got the balloon out of the vessel.No injury to patient 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: 6408540
• Report Number: 2183870-2017-00135
• Device Sequence Number: 635396
• Product Code: LIT
• UDI-Device Identifier: 00821684067147
• UDI-Public: 00821684067147
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: 06/01/2019
• Device Model Number: AB14W060150150
• Device Catalogue Number: AB14W060150150
• Device Lot Number: A287307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1