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

Catalog Number	M00326420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire was used during thrombectomy procedure when the subject guidewire was navigated to the desired location (m2 region), the distal tip of the subject guidewire was broken off in the patient.The physician was able to remove both fractured pieces of the subject guidewire (distal and proximal part) from the patient.The procedure was then successfully completed with another guidewire.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date ¿ added.D4 gtin- added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported fracture was unable to be confirmed and it was unable to be confirmed that the subject device met specification, as the device was not returned.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, during the procedure and navigation of the subject device to the desired location (m2 region) he distal tip of the subject device was broken off in the patient.The physician was able to remove both pieces of the subject device (distal and proximal part).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 severely tortuous.The subject device was not returned for analysis.Based on a review of all available information, it is probable that the subject device was fractured as a result of navigation through the patients severely anatomy.An assignable cause of procedural factors will be assigned to the reported '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 subject guidewire was used during thrombectomy procedure when the subject guidewire was navigated to the desired location (m2 region), the distal tip of the subject guidewire was broken off in the patient.The physician was able to remove both fractured pieces of the subject guidewire (distal and proximal part) from the patient.The procedure was then successfully completed with another guidewire.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 STANDARD PRE-SHAPED 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: 22495866
• Report Number: 3012931345-2025-00117
• Device Sequence Number: 7013711
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: (01)04546540688774(17)270630(10)0000687268
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: M00326420
• Device Lot Number: 0000687268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: HEADWAY 21 MICROCATHETER.
• Patient Sex: Unknown