MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE ACT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	10884450602918
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of cad (coronary artery disease) and cabg (coronary artery bypass graft).Procedure: diagnostic heart cath due to concern for unstable angina.While doing the procedure, the stopcock snapped off of the sheath side port when injecting the groin shot.Catheter was exchanged, no known harm to patient.

• Brand Name: PRELUDE ACT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 17610722
• Report Number: 17610722
• Device Sequence Number: 17757368
• Product Code: DRE
• UDI-Device Identifier: 00884450602911
• UDI-Public: (01)00884450602911(17)260605(10)H2666222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/18/2023
• Report Date (Section F): 08/18/2023

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: 10884450602918
• Device Catalogue Number: PSI-6F-11-038ACT/D
• Device Lot Number: H2666222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 08/18/2023