MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE IDEAL; INTRODUCER, CATHETER

Model Number	10884450381868
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A (b)(6) years-old patient with a history of hypertension was a undergoing a left heart catheterization procedure.While using the prelude ideal¿ vascular catheter introduction set, resistance met and the sheath dilator broke while in vessel.Attending physician removed all pieces, no known harm to patient.New product obtained and procedure done through another site.Sales manufacturer was present during the procedure.

• Brand Name: PRELUDE IDEAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 11684663
• Report Number: 11684663
• Device Sequence Number: 3015515
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)231031(10)H2058771
• 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): 04/08/2021
• Report Date (Section F): 04/08/2021

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: No Information
• Device Model Number: 10884450381868
• Device Catalogue Number: PID6F11021SSC/A
• Device Lot Number: H2058771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1
• Patient Weight: 174
• Date Report Sent to FDA: 04/08/2021