MAUDE Adverse Event Report: Stryker Neurovascular-Utah-Salt Lake City SYNCHRO2-14 STANDARD STRAIGHT 300CM; Wire, Guide, Catheter

Catalog Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during one procedure for middle cerebral artery (mca) stenosis, the physician delivered the intermediate catheter smoothly to the lesion site, then exchanged for the subject guidewire.When torquing the subject guidewire, the physician found that the distal tip of the subject guidewire fractured.The physician then used a gateway balloon to clamp the fractured guidewire and retrieve it.The patient was reported to be fine.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 STANDARD STRAIGHT 300CM
• 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: 50250148
• Report Number: 3012931345-2026-00130
• Device Sequence Number: 10056148
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• 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): 08/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M00326510
• Device Lot Number: 0001005307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2025
• 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: Intermediate catheter (Unknown).; Microcatheter (Unknown).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian