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	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease (cad), deep vein thrombosis (dvt) and recent chest pain.Procedure: l&r coronary angioplasty, l heart cath, percutaneous coronary intervention (pci) in mid- left anterior descending artery (lad) and stent placement.Physician and rn were unable to load sheath onto access wire.No known harm to patient, minor delay.New sheath used without problems.Manufacturer response for introducer, catheter, prelude ideal¿ (per site reporter).Will obtain.

• 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: 14111154
• Report Number: 14111154
• Device Sequence Number: 5191205
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)250103(10)H2320639
• 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): 03/31/2022
• Report Date (Section F): 03/31/2022

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: H2320639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 03/31/2022