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	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of diabetes, coronary artery disease and shortness of breath.While having a diagnostic heart catheterization, the prelude dilator did not have a hole at the end.When irrigated, it was difficult but some irrigant came out through the sides like a sprinkler.No known harm to 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: 10859940
• Report Number: 10859940
• Device Sequence Number: 14193743
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)230816(10)H1911499
• 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): 11/13/2020
• Report Date (Section F): 11/13/2020

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: 10884450381868
• Device Catalogue Number: PID6F11021SSC/A
• Device Lot Number: H1911499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1
• Patient Weight: 157
• Date Report Sent to FDA: 11/13/2020