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	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure the subject guidewire could not be pushed inside the microcatheter.When the physician withdrew the device, the guidewire was found fractured near the distal tip.It was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• 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 ; +1(510)413-2500
• MDR Report Key: 50453716
• Report Number: 3012931345-2026-00131
• Device Sequence Number: 21243798
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K0321746
• 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): 08/26/2026

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: M00313010
• Device Lot Number: 0000813926
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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: 6F long sheath catheter (Likai); React71 thrombus aspiration catheter (Medtronic); Rebar18 microcatheter (Medtronic)
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Race: Asian