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	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension and coronary artery disease presented with shortness of breath.While having a heart catheterization, the device was removed from packaging and the wire was bent.The wire was not used on the patient, no known harm to the patient.

• Brand Name: PRELUDE IDEAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 10739795
• Report Number: 10739795
• Device Sequence Number: 1086689
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)230818(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): 10/16/2020
• Report Date (Section F): 10/16/2020

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: No Information
• Device Model Number: 10884450381868
• Device Catalogue Number: PID6F11021SSC/A
• Device Lot Number: H1911499
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1
• Patient Weight: 126
• Date Report Sent to FDA: 10/16/2020