MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT ST 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).
Event or Problem Description
It was reported that the guidewire (subject device) was used in the medical procedure.However, the subject device got broken during the procedure.No further information available.
Event or Problem Description
It was reported that the guidewire (subject device) was used in the medical procedure.However, the subject device got broken during the procedure.No further information available.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).D4 ¿ expiration date ¿ added, d4 ¿ gtin ¿ updated, d9 - product available to stryker - updated, d9 - 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.During visual inspection, the guidewire was returned in two fragments connected by a stretched platinum coil.The surface of the broken/fractured nitinol tubing was rigid/rough.There was an additional break/fracture of the nitinol tubing towards the distal tip.The core wire distal end was observed through the distal tip dome.A functional inspection was not required as the event was confirmed visually.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.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.It was reported that ¿the wires broke during the procedure.¿.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be not tortuous.There was patient involvement (i.E.The device was in use on the patient at the time of the event).The guidewire was reported to be in good condition during preparation/prior to use on the patient, therefore the damage noted to the returned guidewire indicates it encountered a significant force during the procedure.Based on review of all available information an assignable cause of procedural factors will be assigned to the as reported event of ¿guidewire broken/fractured during use¿ and analysed event of ¿guidewire broken/fractured during use', 'guidewire distal tip broken/fractured during use' and 'guidewire distal tip stretched' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: SYNCHRO SELECT-14 SUPPORT 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: 24757463
• Report Number: 3012931345-2026-00065
• Device Sequence Number: 8743825
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)280715(10)0000887072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/22/2026

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: SSUP215STR
• Device Lot Number: 0000887072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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