MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure for intracranial arterial stenosis, the physician made multiple attempts to deliver the subject guidewire through the lesion site in the m1 segment of the mca but failed.After several attempts, the tip of the subject guidewire broke off.The guidewire was replaced, and the procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure for intracranial arterial stenosis, the physician made multiple attempts to deliver the subject guidewire through the lesion site in the m1 segment of the mca but failed.After several attempts, the tip of the subject guidewire broke off.The guidewire was replaced, and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the proximal end of the guidewire was inspected, and the nitinol tubing was broken/fractured at 293.5cm with the core wire and platinum coil exposed and stretched but not broken.The distal fragment was inspected and the nitinol tubing was broken/fractured 4.5cm from the distal tip with the core wire and platinum coil exposed and stretched but not broken.A functional inspection was not required.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 complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that ¿after shaping the guidewire, the physician made multiple attempts to deliver the guidewire through the lesion site in the m1 segment of the mca, but failed.After several attempts, the tip of the guidewire broke off¿.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no resistance encountered removing the guidewire from the dispenser hoop.There was no indication of a user related issue.The anatomy was reported to be severely tortuous.There were no other difficulties encountered during the usage of the device that could have contributed to the issue.The guidewire tip was not shaped.There was friction/resistance encountered during the procedure.The operator tried to retract and rotate to overcome the resistance.When the physician rotated the guidewire, it got fractured.The wire was torqued to overcome the resistance.The guidewire was positioned within the m1.There was high tortuosity about 4cm from distal tip of guidewire.The same microcatheter was used to finish the procedure.Analysis of the returned guidewire found the nitinol tubing was broken/fractured 293.5cm from the proximal end with the core wire and platinum coil exposed and stretched but not broken.The nitinol tubing was also broken/fractured 4.5cm from the distal tip with the core wire and platinum coil exposed and stretched but not broken also.The damage to the returned guidewire indicates the device encountered a significant force during use most likely as a result of the patient¿s severely tortuous anatomy and the high tortuosity about 4cm from distal tip of guidewire.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire torque problem¿ and as analyzed 'guidewire distal tip broken/fractured during use' and 'guidewire distal tip stretched' 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: SYNCHRO2-14 STANDARD STRAIGHT 300CM
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 23843161
• Report Number: 3012931345-2025-00198
• Device Sequence Number: 9958487
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270912(10)0000722270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053268
• 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): 02/24/2026

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: M00326510
• Device Lot Number: 0000722270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Race: Asian