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	08/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the physician navigated the guidewire (subject device) to the target location the guidewire became unresponsive to the torque control.The physician withdrew the guidewire and observed that the distal tip was stretched and fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure when the physician navigated the guidewire (subject device) to the target location the guidewire became unresponsive to the torque control.The physician withdrew the guidewire and observed that the distal tip was stretched and fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 ¿ expiration date ¿ added d4 ¿ gtin ¿ updated h4 ¿ manufacturing date - added.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 when attempting to super selectively advance the guidewire in combination with the microcatheter to the upper trunk of the m2 segment, the guidewire became unresponsive to torque control.The physician withdrew the guidewire from the body and observed that the distal end of the guidewire exhibited signs of fracture and stretching.Additional information received indicates that the patient's anatomy was severely tortuous.The device was not returned for analysis, however based on the information received, it was stated that the patient's anatomy was severely tortuous.It is known that guidewire fractures may occur if manipulating through tortuous anatomy due to additional stresses that the anatomy can place on the guidewire during manipulation within the anatomy or within the devices being advanced.A guidewire becoming unresponsive to torque control is an indication of a fracture to the guidewire.It is probable that the guidewire was then stretched during the removal of the device.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the reported ¿guidewire torque problem¿, ¿guidewire distal tip stretched¿ and ¿guidewire distal tip 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: 22979599
• Report Number: 3012931345-2025-00149
• Device Sequence Number: 21067369
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)270916(10)0000723924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/13/2025

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: 0000723924
• 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: 08/16/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: ECHELON 10 MICROCATHETER (NON-STRYKER).
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: Asian