MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that the subject guidewire distal tip was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was noted to be kinked to the distal.The nitinol tubing was noted to be fractured at 7 cm from the distal end.There were no anomalies noted to the coating of the hydrated wire.Functional inspection was not performed due to the condition of the device.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 kink was confirmed.The reported difficult to advance and difficult to insert were not replicated, however the analysis results are consistent with the reported event.The device failed to meet specification when received, due to the damage noted.It was reported that the tip of the guidewire was shaped into a 45-degree angle, and then it was delivered through an microcatheter.However, significant resistance was encountered when advancing the guidewire within the microcatheter.The physician withdrew the guidewire and attempted to reinsert it, but resistance persisted.Upon withdrawing the guidewire again for inspection, it was found that the distal end of the guidewire had kinked.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.Resistance was experienced while inserting the subject guidewire into the catheter.The device was returned and it was confirmed that the distal tip was kinked, there was also a fracture to the distal nitinol tubing.It is probable that the device was damaged as a result of the difficulties experienced during the insertion and advancement of the guidewire.An assignable cause of procedural factors will be assigned to the reported 'guidewire distal end/tip kinked/bent' 'guidewire difficult to advance' and 'guidewire difficult to insert' and to the analyzed 'guidewire distal end kinked/bent' and 'guidewire distal tip broken/fractured during use'.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• 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: 22341204
• Report Number: 3012931345-2025-00109
• Device Sequence Number: 9104546
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)260520(10)0000667347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 06/26/2025

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: 05/20/2026
• Device Catalogue Number: M00313010
• Device Lot Number: 0000667347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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 MICROCATHETER (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: Asian