MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire (subject device) was used in the procedure.However, the physician encountered resistance while advancing the subject device.When observed in fluoroscope it was noticed that the distal end of subject device was kinked and fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.
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 guidewire was seen to be kinked/bent 181cm from the proximal end.The nitinol tubing was seen to be broken/fractured at 190cm with the platinum coil and the core wire exposed and broken.The distal end, approximately 10cm was not returned (the fractured distal portion of the guidewire was discarded, and only the proximal portion was retained).Functional inspection was not required as the defect was confirmed visually.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 ¿during an intracranial aneurysm embolization procedure, the physician used a guidewire to advance upward through a microcatheter to the lesion site.During the process, the physician felt resistance while pushing the guidewire.Upon fluoroscopic examination, it was found that the guidewire had become kinked/almost fractured.The physician then promptly withdrew the entire guidewire from the body and discovered that it had kinked and fractured approximately 5 cm from the distal end.The fractured distal portion of the guidewire was discarded, and only the proximal portion was retained¿.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 moderately tortuous.Other devices used in the procedure in conjunction with the subject device was a microcatheter.There were no other difficulties encountered during the usage of the device that could have contributed to the issue.The guidewire tip was shaped from straight tip, shaped to 45°.The wire was not torqued to overcome the resistance.The guidewire was positioned within the internal carotid artery (ica) pcoma when the issue occurred.There was high tortuosity at about 5cm from distal of the kink area.The resistance was noted within the anatomy.As per additional information, the resistance was noted within the anatomy and there was high tortuosity at about 5cm from distal of the kinked area and this would have contributed to the reported event.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of ¿guidewire distal end/tip kinked/bent¿, ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire friction¿ and analysed events of ¿guidewire 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.
Event or Problem Description
It was reported that the guidewire (subject device) was used in the procedure.However, the physician encountered resistance while advancing the subject device.When observed in fluoroscope it was noticed that the distal end of subject device was kinked and fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.

• Brand Name: SYNCHRO2-14 STANDARD STRAIGHT 200CM
• 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: 23813475
• Report Number: 3012931345-2025-00194
• Device Sequence Number: 21157049
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)270811(10)0000707282
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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: M00326410
• Device Lot Number: 0000707282
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: EXCELSIOR SL 10 MICROCATHETER (STRYKER)
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: Asian