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	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a middle cerebral artery (mca) thrombectomy case, the physician observed under imaging that the tip of the subject guidewire had fractured.Subsequently, the physician withdrew the microcatheter and guidewire and found that approximately 7 cm of the tip of the subject guidewire had fractured and frayed.The procedure was completed successfully with another device without any clinical consequences to the patient.
Event or Problem Description
It was reported that during a middle cerebral artery (mca) thrombectomy case, the physician observed under imaging that the tip of the subject guidewire had fractured.Subsequently, the physician withdrew the microcatheter and guidewire and found that approximately 7 cm of the tip of the subject guidewire had fractured and frayed.The procedure was completed successfully with another device without any clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.D4 gtin - 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 and microscopic inspection, it was observed that subject guidewire was returned fractured towards the distal end.The distal end of the guidewire was fractured along the nitinol tubing with the platinum wire exposed and stretched.The distal end of the guidewire was fractured at the nitinol tubing with the platinum wire stretched and the core wire exposed and fractured.The core wire was seen through the distal tip dome.Functional inspection was not required as device was returned fractured.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 guidewire distal tip broken/fractured during use was confirmed during analysis.The device failed to meet specification when received, based on the damage noted.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was moderately tortuous.The same microcatheter was used to finish the procedure.The device was returned and confirmed to be fractured towards the distal tip and there was extensive stretching noted.The available information suggests the patient's anatomy was moderately tortuous, which may have contributed to the reported fracture, and it is likely that the device was stretched during the removal from the patient.An assignable cause of procedural factors will be assigned to the reported and analyzed guidewire distal tip broken/fractured during use and to the 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.

• 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: 22610734
• Report Number: 3012931345-2025-00121
• Device Sequence Number: 5418703
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)271006(10)0000733580
• 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): 10/13/2025

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: 0000733580
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER).
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Asian