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	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection the guidewire was seen to be kinked on the mid-section of the nitinol tubing 171cm from the proximal end.The guidewire was fractured along the nitinol tubing with the platinum wire stretched.Functional testing was not performed due to break.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 event of the guidewire torque problem could not be replicated; however, the analysis results are consistent with the reported event.The reported event of the guidewire kinked/bent was confirmed during analysis.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 removing the guidewire from its packaging, the physician did not deliberately inspect its condition.During the subsequent process of delivering the guidewire along with a microcatheter to the lesion site, the physician found that the guidewire could not be twisted.Despite multiple attempts, it remained un-twistable.The physician then withdrew the guidewire and observed a crease/kink in the middle section.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, 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 and the patients anatomy was not tortuous.The guidewire was returned for analysis, the guidewire was kinked to the nitinol tubing and there was a fracture and to the nitinol tubing and stretching to the platinum coil to the distal end of the guidewire.It was stated that an inspection was not performed on the initial condition of the guidewire, however it cannot be determined if the device damage occurred during preparation.It is probable that there were anatomical and/or procedural factors present during use, which may have caused or contributed to the reported events and to the defects noted to the returned device.An assignable cause of procedural factors will be assigned to the reported event of the guidewire torque problem and guidewire kinked/bent and to the analyzed damage of the guidewire kinked/bent, guidewire distal tip broken/fractured during use and guidewire distal tip stretched, as the issue is associated with a product that meets stryker design and manufacture specifications and was used according to the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject guidewire was returned for analysis and the device was found fractured along the nitinol tubing with the platinum wire stretched.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• 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: 23320025
• Report Number: 3012931345-2025-00172
• Device Sequence Number: 12045973
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)260206(10)0000619472
• 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
• 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 Expiration Date: 02/06/2026
• Device Catalogue Number: M00313010
• Device Lot Number: 0000619472
• 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): Initial
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian