MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO 2/14 200 CM SOFT PRESHAPED; WIRE, GUIDE, CATHETER

Catalog Number	M00326110
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
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 and microscopic examination of the returned device found that guidewire polytetrafluoroethylene (ptfe) coating was scraped in several places along its length and was bent.Functional testing was not performed due to the anomalies found on the guidewire.Since the microcatheter used with the guidewire was not returned it was not possible to determine if the microcatheter contributer to the reported complaint.However, the anomalies found on the guidewire are known to adversely affect the functional performance.The torque device was not returned with the complaint device, so it could not be tested to determine if it contributed to the identified peeling of the ptfe coating, as a result the assignable cause code of undeterminable was assigned to the as analyzed issue.
Event or Problem Description
Based on the investigation of the returned product, the guidewire (subject device) was found to have the polytetrafluoroethylene (ptfe) coating peeling.There were no clinical consequences to the patient.

• Brand Name: SYNCHRO 2/14 200 CM SOFT PRESHAPED
• 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: 8642441
• Report Number: 3012931345-2019-00050
• Device Sequence Number: 14028221
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K053268
• 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
• Report Date (Section B): 05/24/2019

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: 12/17/2021
• Device Catalogue Number: M00326110
• Device Lot Number: 0000019982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1