MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 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	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that flaking of coating of the guidewire was observed before the wire was introduced in the patient.No consequences to the patient were reported.
Additional Manufacturer Narrative
(b)(4).The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the ptfe was peeled/scraped off on several places along its proximal approximately 37.0cm length (from its proximal end).The ptfe coating was scrapped 360 degrees on the wire.The coating was scraped on several places along the guidewire proximal length.The ptfe coating appeared to be scraped off of the guidewire with the torque device collet and/or the introducer.The torque device was not returned.No other anomalies were found on the guidewire.During the functional testing, the returned guidewire was prepped 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 torque device and one to one torque was checked.The guidewire torque was smooth.Additionally, the ptfe coating was tested to ensure acceptable adhesion by wrapping around a 0.140" mandrel.A ptfe coated section was wrapped 10 times around the mandrel in a tight wind and close pitch, and then inspected for anomalies.The ptfe coating showed no anomalies resulting from the test, confirming the ptfe coating met all required specifications.The ptfe coating was adhered to the guidewire.Information provided in the complaint indicated that the guidewire was confirmed to be in good condition prior to use, no resistance was encountered while advancing or retracting the guidewire in the microcatheter and continuous flush was maintained throughout the procedure.The observed peeling ptfe coating is believed to have occurred from an insecurely tightened torque device.Per the device dfu: "securely fasten the torque device onto the wire to prevent slippage of the torque device and to avoid product damage (i.E., core wire abrasion/peeling of ptfe, etc.)." however, because the torque device was not returned for further evaluation.The cause of the reported ptfe coating peeling could not be confirmed.Therefore, an assignable cause of ¿undeterminable¿ has been assigned to this incident.
Event or Problem Description
It was reported that flaking of coating of the guidewire was observed before the wire was introduced in the patient.No consequences to the patient were reported.

• Brand Name: SYNCHRO .014GUIDE WIRE 45 CM TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84119
• MDR Report Key: 7770533
• Report Number: 3008880413-2018-00062
• Device Sequence Number: 13965601
• Product Code: DQX
• UDI-Device Identifier: 07613252186939
• UDI-Public: 07613252186939
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 09/19/2018

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: 03/13/2020
• Device Catalogue Number: M00313020
• Device Lot Number: 0000006039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1