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

Model Number	10884450381868
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A female patient with a history of hypertension, chronic heart failure, and increased shortness of breath was admitted for a left and right cardiac catheterization.The radial wire, from the prelude ideal" vascular catheter introduction set, was bent upon removing it from the package.Device was not used on the patient.

• 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: 11805547
• Report Number: 11805547
• Device Sequence Number: 14542140
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)230930(10)H2032401
• 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): 04/29/2021
• Report Date (Section F): 04/29/2021

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: H2032401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 49
• Date Report Sent to FDA: 04/29/2021