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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that suddenly during the procedure, the operator was unable to torque the guidewire.After pulling back the guidewire, the distal segment was found to be broken and was retrieved in the microcatheter.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that suddenly during the procedure, the operator was unable to torque the guidewire.After pulling back the guidewire, the distal segment was found to be broken and was retrieved in the microcatheter.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.From the condition of the guidewire the functional evaluation could not be performed.The anomalies found on the product are known to adversely affect the functional performance.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The synchro guidewire was examined and it was observed that the guidewire was returned in two fragments.The guidewire polytetrafluoroethylene coating was examined and it was discovered that the polytetrafluoroethylene was peeled off.The condition of the returned guidewire observed during product inspection suggests that excessive torque and manipulation during use resulted in the observed damage.Due to this observation, an assignable cause of handling damage was assigned to the reported event.

• 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: 8406154
• Report Number: 3012931345-2019-00026
• Device Sequence Number: 13917965
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: No Information
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: M00326110
• Device Lot Number: 0000015929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TREVO 18 MICROCATHETER (STRYKER