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

Catalog Number	SSUP215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire (subject device) was used in the medical procedure.However, while advancing the guidewire into the middle cerebral artery the guidewire prolapsed and had difficulty engaging with the target site.When another attempt was made the guidewire was not providing the feedback.The physician removed the guidewire along with the microcatheter and identified the guidewire to be fractured.The physician used a snare device to capture the remaining guidewire.The subject device was replaced, and the procedure was completed successfully with a delay of 10 minutes.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.The reported events could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that the unit was prepped per instruction for use (ifu) and was inserted into a rebar microcatheter by physician after aggressively shaping the wire.While advancing the wire into the middle cerebral artery (mca), the wire prolapsed and then upon advancing again noticed that he very distal end of the wire was not providing 1:1, the wire and microcatheter were then removed with the wire remaining in the guide catheter and internal carotid artery (ica) vessel.The top of the wire was successfully captured using a snare device, no patient was harmed, minor case delay.Additional information provided by the customer indicated that there was stenosis present during the usage of the device that could have contributed to the issue, there was difficulty accessing vessel and there was moderate tortuosity in ica.The guidewire tip was detached around the beveled tip of a base catheter.The subject guidewire was not returned for analysis, however a review of all of the available information suggests that there were multiple factors present during the clinical procedure which may have caused or contributed to the reported event.Also, the aggressive shaping of the wire prior to use may have caused damage to the device.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported 'guidewire distal tip broken/fractured during use, device difficulty engaging target vessel and guidewire torque problem', 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.
Event or Problem Description
It was reported that the guidewire (subject device) was used in the medical procedure.However, while advancing the guidewire into the middle cerebral artery the guidewire prolapsed and had difficulty engaging with the target site.When another attempt was made the guidewire was not providing the feedback.The physician removed the guidewire along with the microcatheter and identified the guidewire to be fractured.The physician used a snare device to capture the remaining guidewire.The subject device was replaced, and the procedure was completed successfully with a delay of 10 minutes.No clinical consequences were reported to the patient.

• Brand Name: SYNCHRO SELECT-14 SUPPORT PS 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: 24147129
• Report Number: 3012931345-2026-00012
• Device Sequence Number: 8969759
• Product Code: MOF
• UDI-Device Identifier: 07613327508635
• UDI-Public: (01)07613327508635(17)281007(10)0001074093
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SSUP215PRE
• Device Lot Number: 0001074093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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: AMPLATZ SNARE (NON- STRYKER).; REBAR MICROCATHETER (NON-STRYKER).; ZOOM 88 GUIDE CATHETER (NON-STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown