MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cerebral angiography and mechanical thrombectomy, an occlusion was found in the m1 segment.When operator attempted to selectively pass through the occluded area to reach the distal m2 segment, the subject guidewire had lost its pushability.The subject guidewire was withdrawn, and it was discovered that it's distal tip had broken inside the catheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during cerebral angiography and mechanical thrombectomy, an occlusion was found in the m1 segment.When operator attempted to selectively pass through the occluded area to reach the distal m2 segment, the subject guidewire had lost its pushability.The subject guidewire was withdrawn, and it was discovered that it's distal tip had broken inside the catheter.The subject device was replaced, and the procedure was completed successfully.No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
There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device was not returned.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 could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that when using a guidewire to selectively pass through the occluded area and reach the distal m2 segment, the surgeon noticed that the guidewire had lost its pushability.The guidewire was then withdrawn, and it was discovered that it had broken inside the catheter.Additional information provided by the customer indicated that the patients anatomy was moderately tortuous and the wire was torqued to overcome the resistance.The device was not returned for analysis, however based on the available information it is probable that the guidewire was fractured as it was torqued to overcome resistance, most likely caused by the patients anatomy, this action is known to cause fractures to the nitinol tubing.An assignable cause of procedural factors will be assigned to the reported event: guidewire distal tip broken/fractured during use, 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 SOFT 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: 21157972
• Report Number: 3012931345-2025-00017
• Device Sequence Number: 7655898
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)270312(10)0000633424
• 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): 03/28/2025

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: M00326010
• Device Lot Number: 0000633424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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: KANGDITAIKE SUPPORING CATHETER (NON-STRYKER); STENT RETRIEVER (UNKNOWN); XINWEI MIDDLE CATHETER (NON-STRYKER); XT27 CATHETER (STRYKER)
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian