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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The guidewire (subject device) was returned for analysis and it was observed that the distal tip of subject guidewire was fractured during use.Also, the mid section of the subject guidewire was noted to be kinked/bent.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire mid-section was seen to be kinked.The guidewire distal end was seen to be eroded (indicative of prolonged exposure to saline during the return process) and fractured along the nitinol tubing in two locations from 191cm.A functional test was unable to be performed due to defects.The reported event of 'guidewire difficult to advance' could not be replicated; however, the analysis results are consistent with the reported event.The device failed to meet specification when returned, based on the damage noted.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 wire was removed from the hoop and hydrated in the bowl with heparinized saline.It was inserted into a flushed the microcatheter and the wire would not advance through the catheter.It was removed and taken off the table and kept to be returned as a complaint to stryker.Additional information received indicates that no anomalies were noted to device after removal from packaging or prior to prep, the device was prepped per dfu by an experienced tech, the device was not recognized to be in bad condition prior to use, continuous flush is used during the procedure.The device was returned and there was a kink noted to the mid-section of the guidewire; there was some fracturing noted to the nitinol tubing towards the distal end of the guidewire.A functional test was unable to be performed, however the damage noted to the device is consistent with the reported difficulty to advance the guidewire.It is probable that there were procedural factors present during use causing the reported difficulty to advance and fracturing to the distal end of the guidewire, it is likely that the guidewire was also kinked and fractured due to the difficulty experienced during advancing the guidewire.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of 'guidewire difficult to advance' and to the analysed 'guidewire distal tip broken/fractured during use' and 'guidewire mid-section kinked/bent', 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.

• 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: 24539086
• Report Number: 3012931345-2026-00044
• Device Sequence Number: 10393812
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: (01)04546540688774(17)280622(10)0000851438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/06/2026

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: M00326420
• Device Lot Number: 0000851438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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: ECHELON 10 MICROCATHETER (NON-STRYKER)
• Patient Sex: Unknown