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

Catalog Number	AB14W020150150
Medical Device Problem Codes	Inflation Problem (1310); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the nanocross was returned for evaluation.No ancillary devices were received.Visual inspection: the nanocross was inspected and the inner was discovered protruding out from a hole from the medial area of the balloon.A tear to the balloon was observed at approximately 6.5cm from the distal tip and continued to approximately to 9.5cm.No damage to the exposed inner was observed.A bend to the catheter was noted at approximately 14.5cm from the distal tip.There was no damage at the proximal end of the catheter shaft.The proximal and distal marker bands were present and accounted for.The distal and proximal ends of the tear was inspected under microscope.The end points of the tear show the balloon material split apart consistent with a tear.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a nanocross device with a 5fr sheath and non-mdt guidewire for treatment of a 110-130mm lesion in the patients posterior tibial artery of diameter 1.5-2.0mm.Vessel was reported to be moderately tortuous, slightly calcified but % stenosis was unknown.A mdt inflation device was used with contrast omnipaque inflation fluid.Embolic protection was not used.It was reported that the device was prepped without issue.The device did not pass through a previously deployed stent.No resistance was encountered nor was excessive force used when advancing the device.Inflation difficulties were experienced at an inflation pressure of 8atm.The inflation could not be observed under fluoro.The device was removed and another nanocross was used to complete the procedure without further issue.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: 7513624
• Report Number: 2183870-2018-00271
• Device Sequence Number: 11122464
• Product Code: LIT
• UDI-Device Identifier: 00821684059326
• UDI-Public: 00821684059326
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K082854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 06/04/2018
• Device Catalogue Number: AB14W020150150
• Device Lot Number: A272947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1