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

Catalog Number	M00326110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cerebral interventional procedure; a portion of the subject guidewire was detached and was not able to be retrieved.No further information is available.
Additional Manufacturer Narrative
D4 expiration date - added.D4 gtin - added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that "during a cerebral interventional procedure, a portion of the guidewire was detached and was not able to be retrieved".Good faith effort attempt was not made to get additional information regarding the event as the initial reporter contact information is unknown.It is possible that the anatomy of the patient may have contributed to the reported event, but this cannot be confirmed.As the device was not returned and the available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during a cerebral interventional procedure, a portion of the subject guidewire was detached and was not able to be retrieved.No further information is available.

• Brand Name: SYNCHRO2-14 SOFT PRE-SHAPED 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: 22877882
• Report Number: 3012931345-2025-00142
• Device Sequence Number: 14874828
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: (01)04546540688736(17)280327(10)000809065
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: M00326110
• Device Lot Number: 000809065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2025
• 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 Sex: Unknown