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	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the procedure, it was reported that the guidewire ptfe (polytetrafluoroethylene) coating was peeled off.Hence the guidewire was changed, and the procedure was completed successfully after.No clinical consequences reported to patient.
Event or Problem Description
During the procedure, it was reported that the guidewire ptfe (polytetrafluoroethylene) coating was peeled off.Hence the guidewire was changed, and the procedure was completed successfully after.No clinical consequences reported to patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the guidewire ptfe (polytetrafluoroethylene) coating was peeling.There was no collet returned with the device.Information provided by the customer indicated that no resistance was felt when advancing the guidewire through the microcatheter, and a torque device was not used prior to noticing the issue.Based on the information currently available the exact cause for reported and analyzed ptfe coating peeling cannot be determined.

• 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 84120
• MDR Report Key: 8834830
• Report Number: 3012931345-2019-00066
• Device Sequence Number: 2196180
• 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): 09/23/2019

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: 06/12/2020
• Device Catalogue Number: M00313020
• Device Lot Number: 0000009888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1