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	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, the distal tip of the subject guidewire was fractured when gaining access into mma branch (middle meningeal artery).Therefore, the stent retriever was used to retrieve the fractured portion from patient¿s neurovasculature successfully.Consequently, the procedure was terminated.The patient is doing fine and there were no reported clinical consequences to the patient.There was a surgical delay of 30 minutes due to the reported event.
Event or Problem Description
It was reported that during procedure, the distal tip of the subject guidewire was fractured when gaining access into mma branch (middle meningeal artery).Therefore, the stent retriever was used to retrieve the fractured portion from patient's neurovasculature successfully.Consequently, the procedure was terminated.The patient is doing fine and there were no reported clinical consequences to the patient.There was a surgical delay of 30 minutes due to the reported event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system 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 guidewire fracture 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 distal tip of wire became detached from proximal end inside patient's head.Physician was able to remove the wire using a trevo stent retriever.As per the additional information, there was difficult, tortuous anatomy, the procedure was an mma (middle meningeal artery) with high tortuosity (and was distal) and the issue was noted when gaining access into mma.The guidewire was not returned for analysis.A review of the available information indicates that there was difficulty and tortuosity in the mma where the treatment was intended.It is probable that there were difficulties caused by the patients anatomy in the mma which led to the subsequent guidewire fracture.An assignable cause of procedural factors will be assigned to the reported 'guidewire broken/fractured during use', 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 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: 23257290
• Report Number: 3012931345-2025-00168
• Device Sequence Number: 21410888
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)260829(10)0000554245
• 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
• Report Date (Section B): 12/16/2025

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 Expiration Date: 08/29/2026
• Device Catalogue Number: SSFT215STR
• Device Lot Number: 0000554245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: MICROCATHETER, 5F DAVIS; SL10 MICROCATHETER (STRYKER); TREVO STENT RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female