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	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire (subject device) got broken within the microcatheter during use.The procedure was completed successfully.No further information available.
Additional Manufacturer Narrative
D9 - product available to stryker - updated.D9 - returned to manufacturer on ¿ updated.H3 - device evaluated by mfg ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal 5.5cm section of the guidewire was confirmed to have been fractured and detached.There was evidence of kinking to the distal tip at approximately 12mm from the distal tip.There was stretching and deformation noted to the platinum coil with the core wire being fractured and fracturing and deformation to the nitinol tubing.A functional test was not required as the guidewire was fractured.The reported guidewire fracture was confirmed during the device analysis.The device failed to meet specification when received, based on the damage noted to the returned 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 wire broke in the catheter.The additional information received indicates that the device was prepared as per the dfu, the device was confirmed to be in good condition prior to use and continuous flush was maintained throughout the procedure.The device was returned and it was confirmed to have been fractured to the distal tip, there was stretching noted to the platinum coil and kinking to the distal tip.The damage noted to the device is indicative of advancing or torquing of the device against resistance.It is probable that there were anatomical and/or procedural factors present during the clinical procedure which caused the guidewire to fracture.Based on review of all available information, an assignable cause of procedural factors will be assigned to the reported 'guidewire broken/fractured during use' and analysed event of ¿guidewire distal tip broken/fractured during use¿ and the analysed event of ¿guidewire distal end kinked/bent and guidewire distal end 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.
Event or Problem Description
It was reported that the guidewire (subject device) got broken within the microcatheter during use.The procedure was completed successfully.No further information available.

• 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: 23354619
• Report Number: 3012931345-2025-00174
• Device Sequence Number: 8871955
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)280323(10)0000807316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 0000807316
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown