MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326010
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the guide wire was found kinked/bent.The device was visually inspected and the (ptfe) polytetrafluoroethylene coating was found missing near the proximal end.Some peeled off coating was received sealed in a plastic bag.The ptfe coating appeared to be scraped off of the guidewire with the insertion tool and/or torque device brass collet.The torque device was not returned.A functional inspection was not performed.The reported event is covered in the device directions for use (dfu).As well, 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 reported event was confirmed (the reported foreign matter was confirmed as ptfe coating).The device failed to meet specifications when received for complaint investigation.The ptfe coating appeared to be scraped off of the guidewire with the insertion tool and/or torque device brass collet.Because this complaint appears to be associated with handling of the product or portion of the product during the procedure a probable cause of handling damage was assigned to the as reported 'device foreign matter and to the as analyzed 'guidewire ptfe coating peeling' and 'guidewire kinked/bent.'.
Event or Problem Description
The guidewire (subject device) was returned for analysis, and it was ptfe (polytetrafluoroethylene) was found missing near the proximal end.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 SOFT STRAIGHT 200CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19618117
• Report Number: 3012931345-2024-00112
• Device Sequence Number: 15194463
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/26/2024

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: 06/16/2022
• Device Catalogue Number: M00326010
• Device Lot Number: 0000028579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL - 10 CATHETER (STRYKER)
• Patient Sex: Unknown