MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH SYNCHRO .014GUIDE WIRE 45 CM TIP; WIRE, GUIDE, CATHETER

Catalog Number	M00313020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that while trying to insert the subject device (guidewire) to microcatheter, the hydrophilic coating was removed/peeled off.The procedure was completed with other wire.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During analysis of the returned device,the guidewire was slightly bent on its distal nitinol section approximately 10cm from its distal end.No anomalies were observed with the hydrophilic coating.However, the ptfe (polytetrafluoroethylene) coating was peeled off on several places approximately 35.0cm from the proximal end.During functional testing, the guidewire was advanced.There was no friction and/or resistance felt during the advancement.The reported complaint that the hydrophilic coating was peeled off and resistance was felt when removing the guidewire from the microcatheter were not confirmed based on the device analysis.Additional information provided by the customer indicated that the guidewire was confirmed to be in good condition after unpacking and during preparation, the device was prepared as per the device directions for use (dfu), continuous flush was maintained throughout the procedure, and resistance was felt while removing the wire from the microcatheter (echelon 10).Since no friction was observed during functional testing of the device with a demo sl-10 microcatheter, it is possible that the echelon 10 microcatheter used in the procedure may have been damaged in its inner lumen causing the analyzed bend on the distal end of the guidewire and reported friction during removal.However, this could not be definitively determined since the microcatheter was not returned for analysis.While there are a number of potential causes for the ptfe coating peel, including insecure tightening of the torque device, because analysis of the device failed to identify a definitive cause and because the torque device was not returned for inspection, an assignable cause of undeterminable was assigned to the analyzed anomalies.
Event or Problem Description
It was reported that while trying to insert the subject device (guidewire) to microcatheter, the hydrophilic coating was removed/peeled off.The procedure was completed with other wire.There were no reported clinical consequences to the patient due to this event.

• Brand Name: SYNCHRO .014GUIDE WIRE 45 CM TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH; 2405 orion circle; west valley city UT 84119
• MDR Report Key: 7858442
• Report Number: 3008880413-2018-00071
• Device Sequence Number: 16200259
• Product Code: DQX
• UDI-Device Identifier: 07613252186939
• UDI-Public: 07613252186939
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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: 07/31/2019
• Device Catalogue Number: M00313020
• Device Lot Number: B47123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 09/08/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICROCATHETER (MEDTRONIC)
• Patient Age: 56 YR