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

Catalog Number	SSTD215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during thrombectomy procedure, when the physician used the subject guidewire to guide the pro18 microcatheter through the blood vessels, he found that the guidewire was difficult to torque control and advance.After withdrawing it for external inspection, it was discovered that the coating at the tip of the guidewire was fractured.Sthe 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 thrombectomy procedure, when the physician used the subject guidewire to guide the pro18 microcatheter through the blood vessels, he found that the guidewire was difficult to torque control and advance.After withdrawing it for external inspection, it was discovered that the coating at the tip of the guidewire was fractured.Sthe 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/microscopic inspection, the guidewire was returned with numerous fractured along the distal end of the nitinol tubing from 209cm with the platinum coil exposed, stretched and the core wire exposed.Unable to perform functional test due to defects.The reported events 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 distal tip broken/fractured during use was confirmed during analysis.The reported guidewire difficulty to advance and guidewire torque problem could not be replicated; however, the analysis results are consistent with the reported event.The device failed to meet specification when returned, based on the damage noted.It was reported that after delivering the long sheath and aspiration catheter into position, when the physician used the subject guidewire to guide the microcatheter through the blood vessels, he found that the guidewire was difficult to torque control and advance.After withdrawing it for external inspection, it was discovered that the coating at the tip of the guidewire was fractured.Additional information provided by the customer indicated that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was moderately tortuous.The same microcatheter was used to finish the procedure, friction/resistance was encountered during the procedure, and the guidewire was positioned within the m1 when the issue occurred.The guidewire was returned and it was confirmed that the distal end of the guidewire had fractured in several locations, there was also evidence of stretching to the platinum coil to the distal end.A functional test was unable to be performed due to the damage noted.The damage noted to the device is consistent with the reported events.It is likely that there may have been some anatomical and/or procedural factors present during use which may have caused or contributed to the reported friction during advancement of the guidewire and subsequent guidewire fracture.An assignable cause of procedural factors will be assigned to the reported guidewire difficult to advance, guidewire distal tip broken/fractured during use and guidewire torque problem and to the analyzed guidewire distal tip broken/fractured during use and guidewire distal tip 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.

• Brand Name: SYNCHRO SELECT-14 STANDARD 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: 24105511
• Report Number: 3012931345-2026-00009
• Device Sequence Number: 5987421
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280607(10)0000843994
• 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): 03/18/2026

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: SSTD215STR
• Device Lot Number: 0000843994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/17/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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: PRO18 MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown
• Patient Race: Asian