MAUDE Adverse Event Report: Stryker Neurovascular-Utah-Salt Lake City SYNCHRO2-14 STANDARD STRAIGHT 200CM; Wire, Guide, Catheter

Catalog Number	M00326410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with a basilar artery tip aneurysm underwent a stent-assisted coil embolization procedure.A subject guidewire positioned the microcatheter in the distal posterior cerebral artery and was then removed.The physician then used the subject guidewire to deliver another microcatheter into the aneurysm sac.However, immediately after the subject guidewire was inserted into the microcatheter, the resistance was encountered and could not be advanced further.Therefore, the subject guidewire was withdrawn, and the distal tip of the subject guidewire was observed to be fractured exactly at the microcatheter hub.Additional information further confirmed that the fractured distal tip of the subject guidewire was within the microcatheter shaft.The microcatheter was removed, and the fractured guidewire segment was successfully retrieved on the table.The subject guidewire was replaced, and the procedure was completed successfully with no reported clinical consequences to the patient.

• Brand Name: SYNCHRO2-14 STANDARD 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 ; +1(510)413-2500
• MDR Report Key: 50475221
• Report Number: 3012931345-2026-00135
• Device Sequence Number: 13361037
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)290103(10)0001249596
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/27/2026

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 Catalogue Number: M00326410
• Device Lot Number: 0001249596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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: Excelsior SL-10 Microcatheter (Stryker)
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Race: Asian