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

Model Number	10884450331719
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Adult female with new onset chest pain needed urgent cath.Procedure: left heart cath.Upon opening the 6.5 prelude sheath inducer, the stopcock was not connected to the sheath tubing.Product not used on the patient.Manufacturer response for dilator, vessel, for percutaneous catheterization, prelude act (per site reporter).Will obtain and replace.

• 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: 13844678
• Report Number: 13844678
• Device Sequence Number: 4013447
• Product Code: DRE
• UDI-Device Identifier: 00884450331712
• UDI-Public: (01)00884450331712(17)240831(10)H2218983
• 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): 03/14/2022
• Report Date (Section F): 03/14/2022

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: 10884450331719
• Device Catalogue Number: PSI-6F-11-038ACT/C
• Device Lot Number: H2218983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 100 KG
• Date Report Sent to FDA: 03/14/2022