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

Catalog Number	M00326420
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found that the ptfe (polytetrafluoroethylene) coating was peeled; no other anomalies were noted.The ptfe coating appeared to have peeled from an insecurely tightened torque device, however, this cannot be conclusively determined as the torque device used in this procedure was not returned for analysis.Based on the information available and investigation results, an assignable cause could not be definitively determined.
Event or Problem Description
Analysis of the returned device found the ptfe (polytetrafluoroethylene) coating was peeled.There was no clinical consequence to the patient as a result.

• Brand Name: SYNCHRO 2/14 200 CM STANDARD 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: 8034189
• Report Number: 3012931345-2018-00024
• Device Sequence Number: 11107503
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/02/2018

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: 02/08/2020
• Device Catalogue Number: M00326420
• Device Lot Number: 0000004702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1