MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 9F X 95CM; Catheter, Percutaneous

Catalog Number	90074
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure for a patient with a right internal carotid artery thrombosis, the physician used a balloon guide catheter to establish access and block antegrade flood flow in the internal carotid artery.The subject balloon guide catheter was successfully delivered to the ica and positioned.The physician began to inflate the balloon guide catheter.When 0.6ml of contrast agent was injected, contrast agent leakage was observed.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: MERCI BGC 9F X 95CM
• Common Device Name: Catheter, Percutaneous
• 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 ; +1(510)413-2500
• MDR Report Key: 25360906
• Report Number: 3012931345-2026-00095
• Device Sequence Number: 10650502
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: (01)00815742000740(17)270127(10)0000782659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112404
• 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): 08/11/2026

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: 90074
• Device Lot Number: 0000782659
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NAVIEN MICROCATHETER (MEDTRONIC).; SOLITAIRE FR STENT RETRIEVER (MEDTRONIC).
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 121 LB
• Patient Race: Asian