MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO .010 WIRE SOFT STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M00316330
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the guidewire was slightly bent on its distal section.During functional testing, the returned guidewire was kept hydrated per dfu and a demo excelsior sl-10 microcatheter was prepared per dfu.The synchro guidewire was loaded and advanced through the proximal end of a demo excelsior sl-10 microcatheter.The guidewire came out of the microcatheter distal end.There was no friction and/or resistance felt during the advancement.The guidewire was attached to a demo torque device and one to one torque was checked.The guidewire torque was not smooth.The guidewire was slightly bent on its distal section.The guidewire polytetrafluoroethylene (ptfe) coating was examined, and it was discovered that the ptfe was peeled/scraped off at approximately between 140.0cm to 145.0cm from the proximal end.The ptfe coating was scraped off of the guidewire with the torque device collet.From the condition of the guidewire it appeared that the torque device had been dragged down the guidewire ptfe.Therefore, an assignable cause code of "use error" was assigned to the analyzed guidewire ptfe coating peeling.The non-smooth torque experience during testing of the guidewire was likely due to the bend found along distal section of the wire.An assignable cause of procedural factors was assigned to the reported and analyzed guidewire kink and analyzed guidewire torque problem.
Event or Problem Description
The investigation of the returned subject device revealed that the polytetrafluoroethylene (ptfe) was peeled/scraped off.There were no clinical consequences to the patient.

• Brand Name: SYNCHRO .010 WIRE SOFT STRAIGHT 300CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8251018
• Report Number: 3012931345-2019-00011
• Device Sequence Number: 1593571
• Product Code: DQX
• UDI-Device Identifier: 07613252187165
• UDI-Public: 07613252187165
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: 11/30/2019
• Device Catalogue Number: M00316330
• Device Lot Number: 0000002025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1