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	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure of m1 segment of right middle cerebral artery (mca), the physician used the subject guidewire with a microcatheter to deliver the distal access catheter into the vessel, and the patient's access was not tortuous.After the subject guidewire reached the m1 segment of the mca, it twisted slightly.Upon fluoroscopic observation, a slight crease/kink was found on the guidewire, so the guidewire was withdrawn for observation, and a fracture mark was discovered from the middle to proximal end of the guidewire.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure of m1 segment of right middle cerebral artery (mca), the physician used the subject guidewire with a microcatheter to deliver the distal access catheter into the vessel, and the patient's access was not tortuous.After the subject guidewire reached the m1 segment of the mca, it twisted slightly.Upon fluoroscopic observation, a slight crease/kink was found on the guidewire, so the guidewire was withdrawn for observation, and a fracture mark was discovered from the middle to proximal end of the guidewire.The subject device was replaced, and the procedure was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
Section d4 expiration date, gitn: updated section h3 device evaluated by mfg.: updated section h4 manufacturing date: updated there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was seen to be kinked at roughly 79cm from the proximal end.The guidewire was found broken in numerous areas 191.6cm, 193.4cm and 193.8cm along the nitinol tubing.The core wire was observed through the distal tip dome.Functional inspection was not performed as the guidewire was broken/fractured was confirmed during visual inspection.The reported event is covered in the device direction 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 damage guidewire broken/fractured during use and guidewire kinked/bent was confirmed.The device failed to meet specifications when returned for analysis.It was reported that after the guidewire reached the m1 segment of the middle cerebral artery (mca), it twisted slightly.Fluoroscopic observation revealed a slight crease or kink on the guidewire, prompting the operator to withdraw the device.Upon withdrawal, the guidewire was found to be fractured.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 device was returned for analysis and was found to be kinked at roughly 79cm from the proximal end.The guidewire was found broken in numerous areas 191.6cm, 193.4cm and 193.8cm along the nitinol tubing.It is probable that angulation within the mca region, contributed to the initial resistance encountered (evidently provided in the event details that the guidewire twisted after reaching the m1 segment).In an attempt to advance the guidewire past this resistance, the device may have been subjected to additional torquing.The combination of challenging anatomy and repeated torquing to overcome resistance may have resulted in stress accumulation to the device, ultimately leading to the observed kink and fracture on the guidewire.It is probable that there may have been anatomical and/or procedural factors present during the clinical procedure that may have caused the reported guidewire fracture.An assignable cause of procedural factors will be assigned to the as reported damage of as well as analyzed damage of guidewire broken/fractured during use and guidewire kinked/bent, as the issue is associated with a product that meets company¿s 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 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: 22610753
• Report Number: 3012931345-2025-00120
• Device Sequence Number: 5494616
• 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): 08/12/2025

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: 0000720816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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: TREVO PRO 18 MICROCATHETER (STRYKER).
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: Asian