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

Catalog Number	AB14W050120150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
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
It was reported that the physician used a nanocross device with a spider fx and non-mdt inflation device for the treatment of a severely calcified lesion in the mid-left superficial femoral artery (sfa).The lesion was reported to exhibit 50% stenosis and the vessel was reported to be slightly tortuous.The device was prepped as per ifu without issue.Contrast and heparinized saline solution was used for inflation.The device did not pass through a previously deployed stent and there was resistance experienced during advancement of the device.It was reported that following the first inflation of the device to 10 atm a pin hole burst was observed.The balloon did not fragment and was reported to have been retrieved successfully.Another nanocross was used to complete the procedure without further issue.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: 7410603
• Report Number: 2183870-2018-00216
• Device Sequence Number: 19194102
• Product Code: LIT
• UDI-Device Identifier: 00821684066966
• UDI-Public: 00821684066966
• 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): 04/10/2018

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: 07/07/2020
• Device Catalogue Number: AB14W050120150
• Device Lot Number: A487977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1