MAUDE Adverse Event Report: COVIDIEN NITREX NITINOL GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	N352601
Medical Device Problem Code	Delamination (2904)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the returned specimen consists of one-1 each mjncca-x, int, ptfe 260-035; returned still loaded within a trailblazer support catheter.The device presents bend damage at 2.02 to 3.31cm from the distal tip, and pinch damage to the ptfe sleeve 76.8 to 79.6cm from the distal tip.The pinch damage presents witness impressions consistent with a torque device or similar constraint device and results in an out of round condition.The proximal 0.64mm of the ptfe sleeve present tear damage.No other damage or inconsistencies are noted to the specimen.All joints appear to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appears visually and dimensionally correct.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the spider fx and nitrex guidewire as per ifu.It was reported the trailblazer catheter was loaded onto nitrex wire and met resistance and was unable to pass further.The spider was loaded into delivery catheter; resistance was encountered resulting in a kink in the spider.Both devices were replaced and used with the trailblazer catheter for the procedure.No injury to the patient reported.

• Brand Name: NITREX NITINOL GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane; plymouth MN 55442
• MDR Report Key: 6640999
• Report Number: 2183870-2017-00258
• Device Sequence Number: 602527
• Product Code: DQX
• UDI-Device Identifier: 00821684065495
• UDI-Public: 00821684065495
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040345
• 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): 05/15/2017

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: 09/01/2019
• Device Model Number: N352601
• Device Lot Number: 10737271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1