MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MARQUIS® STOPCOCK

Catalog Number	H3RRC
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during a cath lab procedure, two stopcocks had to be used due to cracking when being tightened onto the manifold.They stated there was no excessive force or pressure applied prior to the device cracking.These two stopcocks were disposed of.A third stopcock was applied without issue.After the cath lab procedure the patient was transferred to the icu per normal hospital protocol.Several hours later, the patient's art line blood pressure reading dropped.The nurse entered the room and noticed blood on the floor and bedsheets.The nurse pulled back the top sheet and noted blood "spurting" from the stopcock.The nurse noted a visible crack in the stopcock where the blood was leaking.It was reported the stopcock functioned without issue for several hours prior to the blood leakage event.The patient later expired due to their co-morbid conditions.The icu nurse manager reports the blood loss was not the direct cause of death for the patient but that it "didn't help".
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: MARQUIS® STOPCOCK
• Common Device Name: STOPCOCK
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23810388
• Report Number: 1721504-2025-00722
• Device Sequence Number: 18481663
• Product Code: DTL
• UDI-Device Identifier: 00884450011324
• UDI-Public: 00884450011324
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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?: Yes
• Device Catalogue Number: H3RRC
• Device Lot Number: H3305016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown