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 Codes	Perforation of Vessels (2135); Coma (2417)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during stenosis in the left middle carotid artery (mca) procedure, the operator established access using a long sheath.Next, the operator used the subject guidewire along with the balloon guide catheter to past the stenotic lesion.During this process, the guidewire inadvertently perforated the vessel, and extravasation of contrast agent was observed under angiography.Following the incident, balloon inflation was used to apply pressure at the site of injury, and subsequent angiography showed no further contrast agent extravasation.The interventional procedure was then terminated, and the patient was transferred to the intensive care unit (icu).Currently, the patient remains in a coma.
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 the subject guidewire inadvertently perforated the vessel, causing the extravasation of contrast agent.A balloon inflation was used to apply pressure at the site of injury and subsequent angiography showed no further contrast agent extravasation.The interventional procedure was then terminated, and the patient was transferred to the intensive care unit (icu).Currently, the patient remains in a coma.Additional information did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.The tortuosity of the patient's anatomy was moderately tortuous which may have contributed to the reported event.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported events: ¿patient vessel perforation' and ¿patient complications'.
Event or Problem Description
It was reported that during stenosis in the left middle carotid artery (mca) procedure, the operator established access using a long sheath.Next, the operator used the subject guidewire along with the balloon guide catheter to past the stenotic lesion.During this process, the guidewire inadvertently perforated the vessel, and extravasation of contrast agent was observed under angiography.Following the incident, balloon inflation was used to apply pressure at the site of injury, and subsequent angiography showed no further contrast agent extravasation.The interventional procedure was then terminated, and the patient was transferred to the intensive care unit (icu).Currently, the patient remains in a coma.

• 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: 21159630
• Report Number: 3012931345-2025-00018
• Device Sequence Number: 15361285
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270312(10)0000633356
• 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): 03/26/2025

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: 0000633356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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: GATEWAY BALLOON CATHETER (STRYKER).; LONG SHEATH (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Patient Race: Asian