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	09/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire was kinked.The subject device was returned for analysis and the device investigation revealed that the subject guidewire was broken/fractured during use.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
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire distal end was noted to be broken/fractured and kinked/bent.No other anomalies were noted.The functional inspection was not required.The reported event ¿guidewire kinked/bent¿ was confirmed.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 as per the physician there was severe resistance while advancing the coil within the micro catheter, hence coils were removed and procedure completed with other coils, procedure was uneventful.The wire was kinked and had to use one more wire.As per the additional information, the patients anatomy was moderately tortuous.During analysis, the guidewire was found to be kinked and fractured along the distal tip.A review of the available information indicates that there was difficulty advancing the target coils also.It is possible that the patients anatomy caused some resistance during advancement of the coils and the guidewire, and subsequent kinking to the guidewire.An assignable cause of procedural factors will be assigned to the reported event ¿guidewire kinked/bent¿, 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.An assignable cause of procedural factors will be assigned to the analyzed event ¿guidewire distal end/tip kinked/bent¿ 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: 25212439
• Report Number: 3012931345-2026-00091
• Device Sequence Number: 10574047
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)261113(10)0000586380
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 05/19/2026

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: 0000586380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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: EXCELSIOR SL10 MICROCATHETER (STRYKER).; TARGET COIL (STRYKER).
• Patient Age: 40 YR
• Patient Sex: Male