MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HONOR; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	00884450013137
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During injection of contrast into the right pulmonary vein, the hemostatic valve separated into two pieces.No air was introduced, the catheter and valves were removed, new valve attached, and the study was completed.Manufacturer response for adaptor, stopcock, manifold, fitting, cardiopulmonary bypass, honor (per site reporter).Vendor rep was notified.Remaining stock from lot was removed from use.

• Brand Name: HONOR
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 17949089
• Report Number: 17949089
• Device Sequence Number: 20750758
• Product Code: DTL
• UDI-Device Identifier: 00884450013137
• UDI-Public: (01)00884450013137
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/04/2023
• Report Date (Section F): 10/04/2023

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 Model Number: 00884450013137
• Device Catalogue Number: MAP300
• Device Lot Number: K2438928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 80 KG
• Date Report Sent to FDA: 10/04/2023