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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction

• 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 ; +1(510)413-2500
• MDR Report Key: 25764490
• Report Number: 3012931345-2026-00107
• Device Sequence Number: 13236381
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)281123(10)0001173824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/10/2026

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: M00326010
• Device Lot Number: 0001173824
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: Asian