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	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure for the middle cerebral artery internal carotid artery lesion, the physician attempted to pass the guidewire through the lesion site.When manipulating the proximal end of the guidewire, there was no feedback from the distal end.The physician immediately withdrew the guidewire and found that it had fractured.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D2a -common device name- corrected to wire, guide, catheter.D4- expiration date-updated.D9 - product available to stryker - updated.D9 - returned to manufacturer on - updated.H3 - device evaluated by mfg ¿ updated.Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection it was noted that the guidewire was returned and was noted to be broken/fractured approx.191 cm from the proximal end.There was evidence of stretching to the distal coil.The core wire distal end was observed through the distal tip dome.The functional inspection was not required.The reported event guidewire broken/fractured during use was confirmed during analysis.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 physician attempted to pass the guidewire through the lesion site, repeatedly rotating it clockwise and counterclockwise.When manipulating the proximal end of the guidewire, there was no feedback from the distal end.The physician immediately withdrew the guidewire and found that it had fractured.During analysis, the guidewire was noted to be fractured with stretching noted to the distal coil.Additional information indicates that continuous flush was set up and maintained throughout the clinical procedure, the patient¿s anatomy was moderately tortuous.It is probable that the guidewire fractured as a result of the repeated rotating and manipulation of the guidewire during the attempt to pass the guidewire through the lesion site.Based on the review of all available information an assignable cause of procedural factors will be assigned to the reported event guidewire broken/fractured during use and to the analyzed event guidewire 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.
Event or Problem Description
It was reported that during a procedure for the middle cerebral artery internal carotid artery lesion, the physician attempted to pass the guidewire through the lesion site.When manipulating the proximal end of the guidewire, there was no feedback from the distal end.The physician immediately withdrew the guidewire and found that it had fractured.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 23721314
• Report Number: 3012931345-2025-00192
• Device Sequence Number: 8532046
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)270909(10)0000720816
• 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): 01/08/2026

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: 0000720816
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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: AXS CATALYST7 CATHETER (STRYKER)
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: Asian