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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 3 of 3 reports.
Event or Problem Description
It was reported that during testing in challenge silicone models, the hypo tube of the subject guidewire broke.The guidewire remained intact and did not separate into parts.No patient was involved, and no other information was provided.

• 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 ; 5104132500
• MDR Report Key: 23951539
• Report Number: 3012931345-2026-00003
• Device Sequence Number: 13424068
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)280623(10)0000851946
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: Other
• Device Catalogue Number: SSFT215STR
• Device Lot Number: 0000851946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT 5 (STRYKER); INFINITY LS (STRYKER); SL10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown