MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a basilar artery (ba) thrombectomy procedure, the thrombus was distributed throughout the entire length of the ba.The operator selected a microcatheter and a subject guidewire to establish the pathway.After normal flushing and wetting of the products, the microcatheter was delivered.When the microcatheter reached the proximal end of the thrombus, the operator advanced the subject guidewire through the thrombus into the posterior cerebral artery (pca) in order to deliver the microcatheter past the thrombus.However, when the subject guidewire reached the middle segment of the thrombus, significant resistance was encountered, preventing further advancement of the subject guidewire.The operator twisted and adjusted the tip of the subject guidewire, but it still could not pass through the lesion.Next, the operator withdrew the subject guidewire into the microcatheter and planned to reshape the tip of the subject guidewire before attempting again.After retracting the tip of the guidewire into the microcatheter, the operator continued to withdraw the subject guidewire but found that it had fractured approximately 35 cm from the 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
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that during a basilar artery (ba) thrombectomy procedure, the thrombus was distributed throughout the entire length of the ba.The operator selected a microcatheter and a subject guidewire to establish the pathway.After normal flushing and wetting of the products, the microcatheter was delivered.When the microcatheter reached the proximal end of the thrombus, the operator advanced the subject guidewire through the thrombus into the posterior cerebral artery (pca) in order to deliver the microcatheter past the thrombus.However, when the subject guidewire reached the middle segment of the thrombus, significant resistance was encountered, preventing further advancement of the subject guidewire.The operator twisted and adjusted the tip of the subject guidewire, but it still could not pass through the lesion.Next, the operator withdrew the subject guidewire into the microcatheter and planned to reshape the tip of the subject guidewire before attempting again.After retracting the tip of the guidewire into the microcatheter, the operator continued to withdraw the subject guidewire but found that it had fractured approximately 35 cm from the 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: SYNCHRO-14 STRAIGHT 200-35CM
• 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: 22731856
• Report Number: 3012931345-2025-00133
• Device Sequence Number: 21080108
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)260521(10)0000667798
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 10/31/2025

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 Expiration Date: 05/21/2026
• Device Catalogue Number: M00313010
• Device Lot Number: 0000667798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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-27 MICROCATHETER (NON-STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian