MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that subject guidewire distal tip was broken/fractured during use.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
This is 2 of 2 reports - 2nd mdr.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was fractured along the nitinol tubing at 290cm , the platinum wire was stretched and the core wire was exposed.A functional inspection was not required.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 guidewire distal tip stretched 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 during the super-selective catheterization, the subject guidewire was stretching.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 patient's anatomy was severely tortuous.During analysis, the guidewire was fractured along the nitinol tubing at 290cm, the platinum wire was stretched, and the core wire was exposed.The guidewire likely fractured due to severe tortuosity of the patient¿s vessels, which might have caused excessive bending and torsional stress during super-selective catheterization.In the follow up gfes it was mentioned that the issue occurred in the area distal to the ica, where the tortuous anatomy might have contributed to stretching and subsequent damage to the guidewire.An assignable cause of procedural factors will be assigned to as reported 'guidewire distal tip stretched' as well as analyzed 'guidewire distal tip stretched¿, 'guidewire distal tip broken/fractured during use', as this complaint appears to be associated with a product that met stryker design and specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 23964372
• Report Number: 3012931345-2026-00005
• Device Sequence Number: 17345997
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)270219(10)0000792315
• 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): 01/05/2026

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: M00313310
• Device Lot Number: 0000792315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 64 YR
• Patient Sex: Male
• Patient Race: Asian