MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the physician was using the subject guidewire, the tip of the subject guidewire adhered to the intima of the blood vessel.After withdrawing the guidewire out of the body, the physician found that the guidewire was attached with intimal tissue.No additional information available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 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 an aneurysm interventional procedure, when the physician was using a subject guidewire (a 3-meter exchange guidewire), the tip of the guidewire adhered to the intima of the blood vessel.After withdrawing the guidewire out of the body, the physician found that the guidewire was attached with intimal tissue".There was an adverse event that reported "guidewire was attached with intimal tissue." it was reported that the tip of the guidewire went into the distal of the vessel.No impact reported to the patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the as reported device difficulty engaging target vessel and unexpected movement of device.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vessel perforation¿ as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported that when the physician was using the subject guidewire, the tip of the subject guidewire adhered to the intima of the blood vessel.After withdrawing the guidewire out of the body, the physician found that the guidewire was attached with intimal tissue.No additional information available.

• Brand Name: SYNCHRO2-14 STANDARD STRAIGHT 300CM
• 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: 22983082
• Report Number: 3012931345-2025-00150
• Device Sequence Number: 9549333
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270312(10)0000633359
• 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): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M00326510
• Device Lot Number: 0000633359
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: Asian