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	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 8 of 8 reports (8th mdr).
Event or Problem Description
It was reported that the subject guidewire had proximal bond joints break during simulated use testing in challenge silicone models.The guidewires remained intact and did not separate into parts.No patient was involved.
Additional Manufacturer Narrative
This is 8 of 8 reports (8th mdr).There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted 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 guidewire fracture could not be confirmed and it could not be confirmed that the device met specification, as the device was not returned.It was reported that stryker research & development simulated use testing in challenge silicone models, engineers designed and selected the models to test the limits of the subject guidewire.Guidewires had proximal bond joints break.The guidewires remained intact and did not separate into parts.Please note that these silicone models have extreme tortuosity and are designed to test the edge of failure of the guidewire devices.The testing program is tasked with creating a more robust and durable guidewire and thus the testing process requires that we use a control like subject guidewire.The devices were not returned for analysis.As the devices were used in a sim use model to test the devices to the edge of failure, a assignable cause of user error will be assigned to this complaint.
Event or Problem Description
It was reported that the subject guidewire had proximal bond joints break during simulated use testing in challenge silicone models.The guidewires remained intact and did not separate into parts.No patient was involved.

• 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: 21126405
• Report Number: 3012931345-2025-00015
• Device Sequence Number: 7583461
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)250827(10)0000176833
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: Other
• Device Expiration Date: 08/27/2025
• Device Catalogue Number: M00326010
• Device Lot Number: 0000176833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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 Sex: Unknown