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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing in challenge silicone models, the proximal bond joint of the subject guidewire broke.No patient was involved.
Additional Manufacturer Narrative
This is 2 of 3 mdr reports.
Additional Manufacturer Narrative
D4 expiration date ¿ added.D4 gtin- added.D9 product available to stryker / returned to manufacturer on ¿ updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection was performed as the proximal bond was fractured.The nitinol tubing was fractured at approx.10cm from the distal end.There was some bending/kinking noted to the distal end.Functional test was not performed due to the condition of the returned device.The reported 'guidewire broken/fractured during use' was confirmed during analysis.The subject device failed to meet specification based on the damage noted.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.This subject device was used as part of stryker r&d simulated use testing in challenge silicone models with zion team members, designed and selected the models to test the limits of synchro select soft.The subject guidewire had proximal bond joints break.The subject guidewire remained intact and did not separate into parts.Please note that these silicone models have extreme tortuosity and are designed to test the edge of failure of the subject guidewire device.The subject device was returned and confirmed that the proximal bond had been cracked/fractured.There was also fracturing noted to the nitinol tubing and kinking to the distal end of the nitinol tubing also.It is probable that the subject guidewire was fractured and damaged as a result of the extreme testing conditions that it was exposed to during sim use testing with the intent of testing the device to the edge of failure.An assignable cause of use error will be assigned to the reported and analyzed ' guidewire broken/fractured during use' and to the analyzed ¿ guidewire distal end/tip kinked/bent¿ as the intent of the testing was to test the subject device to the edge of failure.
Event or Problem Description
It was reported that during testing in challenge silicone models, the proximal bond joint of the subject guidewire broke.No patient was involved.

• 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: 24348441
• Report Number: 3012931345-2026-00031
• Device Sequence Number: 17330824
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)280920(10)0001028075
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 001028075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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: CATALYST 5 (STRYKER); INFINITY (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown