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

Model Number	N351452
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the nitrex wire was returned for evaluation.The device returned coiled, loose and double-bagged within ¿zip-lock¿ style poly biohazard pouches.The specimen presented an overall length of 145.15cm, a finished coil length of 6.02¿/15.30cm, a ptfe jacketed shaft diameter of.03330¿ to.03360¿ and a finished coil diameter of.03490¿ to.03495¿.The specimen presented an angled tip length of.433¿/1.10cm, and a tip angle of 53.5 degrees.A gage bushing certified to be.0355¿ passed over the length of the specimen from the distal end with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity to the distal aspect of the jacket damage.The specimen presented torn/frayed ptfe jacket material over the proximal 0.25cm and dried blood-like material on and between the coil wraps.All joints appeared to be correct and intact.Except where noted, the specimen device appeared visually and dimensionally correct.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a nitrex guide wire along with 7fr sheath during procedure to treat a fibrous soft tissue lesion in the dialysis access circuit.Ifu was followed.Damaged component was noted during preparation, the end of the guide wire was frayed at the blue (non tip) end.The issue was not noted prior to introducing the device into the patient and the device entered the patient's vasculature.It was reported that physician had to up size sheath, pass a buddy wire through lesion then remove nitrex to load a pta balloon on new wire to complete procedure.There was no patient injury reported.

• Brand Name: NITREX NITINOL GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10086353
• Report Number: 2183870-2020-00151
• Device Sequence Number: 11506728
• Product Code: DQX
• UDI-Device Identifier: 00821684058275
• UDI-Public: 00821684058275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/26/2020

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: 11/01/2022
• Device Model Number: N351452
• Device Catalogue Number: N351452
• Device Lot Number: 11193082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR