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	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the aneurysm embolization case, resistance was encountered when the subject guidewire was delivered inside the guide catheter.Under the x-ray it was found that the distal tip of subject guidewire was kinked, and when it was retrieved, it was found that 10 cm from the distal end of subject guidewire was fractured.The subject guidewire was replaced, and procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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 inspection, the guidewire was seen to be kinked/bent.The guidewire was seen to be broken/fractured and stretched 191 cm from the proximal end.The guidewire distal end was seen to be kinked/bent.The core wire distal end was observed through the distal tip dome.The guidewire ptfe was seen to be damaged approx.30 cm from the proximal.The functional inspection could not be performed due to the damage noted to the guidewire.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 kinked/bent and broken fractured during use were confirmed.The reported guidewire difficult to advance could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specification when received due to the damage noted.It was reported that when using a guidewire to deliver inside the guide catheter, the operator felt resistance.Under x-ray it could be found the guidewire kinked in the catheter.Withdrew it out and found 10cm from distal of guidewire was fractured.Additional information received 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 patient's anatomy was not tortuous.The guidewire tip was shaped 45°.The wire was not torqued to overcome the resistance.The device was returned, and it was confirmed that the distal end had been fractured, there was also stretching and kinking noted to the distal end.There was some kinking and damage to the ptfe coating noted to the proximal end of the guidewire.It is probable that there were anatomical and/or procedural factors present during the clinical procedure which caused the reported difficulty to advance the guidewire and the subsequent fracture and stretching noted to the returned device.An assignable cause of procedural factors will be assigned to the reported guidewire difficult to advance, guidewire distal end/tip kinked/bent and guidewire distal end/tip broken/fractured during use and to the analysed guidewire distal end/tip kinked/bent, guidewire distal tip stretched and guidewire distal tip broken/fractured during use, as the issue is associated with a product that meets company¿s 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.It is probable that the proximal end of the guidewire was kinked as a result of handling of the device.The proximal ptfe coating damage is indicative of damage from the torque device, either due to an under tightened torque device or removal of the torque device after use.An assignable cause of handling damage will be assigned to the analysed guidewire kinked/bent and guidewire ptfe coating peeling.
Event or Problem Description
It was reported that in the aneurysm embolization case, resistance was encountered when the subject guidewire was delivered inside the guide catheter.Under the x-ray it was found that the distal tip of subject guidewire was kinked, and when it was retrieved, it was found that 10 cm from the distal end of subject guidewire was fractured.The subject guidewire was replaced, and procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 21840640
• Report Number: 3012931345-2025-00078
• Device Sequence Number: 15628101
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)270701(10)0000688141
• 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): 06/25/2025

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: 0000688141
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: GUIDE CATHETER (MANUFACTURER: UNKNOWN).
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: Asian