MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the delivery of the subject guidewire to the distal end of the m1 segment, the physician slightly twisted and controlled the guidewire.The physician noticed signs of breakage in the middle section of the subject 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
D4 expiration date: updated.D4 gtin: updated.D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H4 manufacturing date: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject guidewire was noted to be fractured and extensively stretched in numerous areas along the nitinol tubing.The guidewire was seen to be kinked roughly 55.5cm from the proximal end.There were small fractures starting at 288cm.The core wire and nitinol tube were fractured and the platinum wire extremely stretched.The core wire was seen through the distal tip dome.The functional inspection was not performed.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 broken/fractured during use' was confirmed during the analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that, when delivering the 3-meter guidewire to the distal end of the m1 segment, the physician slightly twisted and controlled the guidewire and noticed signs of breakage.The 3-meter guidewire was then withdrawn and replaced with a new 3-meter guidewire.Additional information provided by the customer indicated that continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The guidewire was returned and found to be fractured in numerous locations with significant stretching noted.Based on the device analysis and a review of all available information, it is probable that the guidewire was fractured and stretched as a result of navigation through the patient¿s tortuous anatomy.An assignable cause of procedural factors will be assigned to the reported and analyzed damage guidewire broken/fractured during use, and to the analyzed damage guidewire kinked/bent and 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.
Event or Problem Description
It was reported that during the delivery of the subject guidewire to the distal end of the m1 segment, the physician slightly twisted and controlled the guidewire.The physician noticed signs of breakage in the middle section of the subject guidewire.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 300CM
• 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: 22681500
• Report Number: 3012931345-2025-00127
• Device Sequence Number: 21200482
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270729(10)0000700271
• 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): 10/17/2025

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: M00326510
• Device Lot Number: 0000700271
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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: CATALYST 5 (STRYKER).; TREVO PRO 18 MICROCATHETER (STRYKER).
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: Asian