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	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire (subject device) was selected for a thrombectomy procedure for middle cerebral artery occlusion.However, difficulty was encountered by the physician when an attempt was made to pass the guidewire through the thrombus.The physician withdrew the guidewire and observed a crack at the distal tip.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
A2 ¿ age at the time of event - added.A2 ¿ age units (patient) ¿ added.A4 ¿ weight ¿ added.A4 ¿ weight units ¿ added.C2 / d10 ¿ concomitant products grid ¿ added.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 distal 8cm section of the guidewire was noted to be fractured to the nitinol tubing and core with extensive stretching noted to the platinum wire.There were no anomalies noted to the hydrated wire.A functional test was unable to perform due to damage.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 distal tip broken/fractured during use was confirmed.The reported guidewire torque problem could not be replicated; however, the analysis results are consistent with the reported event.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that while attempting to navigate the guidewire through the thrombus, the physician experienced difficulty in manipulating and advancing it.As a result, the guidewire was withdrawn, and a crack was observed at its distal tip.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.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.The patient's anatomy was moderately tortuous.It is probable that the device experienced difficulties to pass through the lesion along with the tortuous anatomy, causing the damage noted to the device during analysis.It is likely that the damage to the device was perceived to be stretching and fractures.Based on the review of all available information, an assignable cause of procedural factors will be assigned to as reported ¿guidewire distal tip broken/fractured during use¿, ¿guidewire torque problem¿ as well as analyzed ¿guidewire distal tip broken/fractured during use¿, ¿ guidewire distal tip stretched¿ as the complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that the guidewire (subject device) was selected for a thrombectomy procedure for middle cerebral artery occlusion.However, difficulty was encountered by the physician when an attempt was made to pass the guidewire through the thrombus.The physician withdrew the guidewire and observed a crack at the distal tip.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: 22046447
• Report Number: 3012931345-2025-00096
• Device Sequence Number: 9095830
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)270930(10)0000730513
• 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): 06/25/2025

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: 0000730513
• 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: 04/26/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: REBAR 18 MICROCATHETER (NON-STRYKER)
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: Asian