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	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension and obesity.Procedure is diagnostic heart catheter; the physician was unable to pass wire of the 6f prelude, sheath introducer through inner dilator.No known harm to 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: 11503869
• Report Number: 11503869
• Device Sequence Number: 4140314
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)231222(10)H2009624
• 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): 03/16/2021
• Report Date (Section F): 03/16/2021

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: H2009624
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1
• Patient Weight: 137
• Date Report Sent to FDA: 03/16/2021