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	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm embolization procedure, abnormal guidewire manipulation was observed during the super selective catheterization process.Upon withdrawing the subject guidewire for inspection, a suspected fracture at the guidewire's distal tip was identified.The subject guidewire was positioned in the middle cerebral artery (mca) when the issue occurred.The 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
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was kinked at 61cm from the distal end.The distal tip of the guidewire was confirmed to be fractured and kinked with stretching to the platinum wire - (the distal tip was not returned).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 guidewire fracture was confirmed.The device failed to meet specification when returned for analysis.It was reported that, after thorough pre-operative flushing, abnormal manipulation of the guidewire was observed during the superselective catheterization process.Upon withdrawing the guidewire for inspection, a suspected fracture was identified at its distal tip.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was moderately tortuous.The wire was torqued to overcome the resistance.It is probable that the guidewire was fractured as it was torqued to overcome resistance.As per the synchro ifu: "never advance, auger, withdraw, or torque a guidewire which meets resistance.Resistance may be felt and/or observed under fluoroscopy by noting any buckling or prolapse of the guidewire tip.Excessive force against resistance may result in damage to the guidewire, such as separation of the guidewire tip, damage to the interventional device, and/or vessel perforation.Determine the cause of the resistance under fluoroscopy and take any necessary remedial action".An assignable cause of procedural factors will be assigned to the reported and analyzed 'guidewire distal tip broken/fractured during use' as well as analyzed '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.It is probable that the proximal end of the guidewire was kinked as a result of handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the analyzed 'guidewire kinked/bent' as this complaint appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported that during an aneurysm embolization procedure, abnormal guidewire manipulation was observed during the super selective catheterization process.Upon withdrawing the subject guidewire for inspection, a suspected fracture at the guidewire's distal tip was identified.The subject guidewire was positioned in the middle cerebral artery (mca) when the issue occurred.The subject device 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: 22028832
• Report Number: 3012931345-2025-00093
• Device Sequence Number: 8503513
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)270305(10)0000630727
• 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): 06/19/2025

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: M00326410
• Device Lot Number: 0000630727
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: ECHO-10 CATHETER (NON-STRYKER)
• Patient Sex: Unknown