MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT ST 215CM; Guide, Wire, Catheter, Neurovasculature

Catalog Number	SSFT215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction

• Brand Name: SYNCHRO SELECT-14 SOFT ST 215CM
• Common Device Name: Guide, Wire, Catheter, Neurovasculature
• 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: 25775447
• Report Number: 3012931345-2026-00108
• Device Sequence Number: 21218764
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)281214(10)0001221150
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202522
• 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,Followup
• Report Date (Section B): 09/23/2026

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: SSFT215STR
• Device Lot Number: 0001221150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• 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: 06/19/2026
• Supplement Date Received by Manufacturer: 08/28/2026; 09/23/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/16/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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 Sex: Unknown