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

Model Number	10884450467951
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with coronary artery disease and hypertension.Procedure: dual icd (implantable cardioverter-defibrillator) implantation- when package was opened, dilator was not tapered at the end.No tip found in packaging.Not used on patient.Manufacturer response for introducer, catheter, prelude snap (per site reporter) will obtain.

• Brand Name: PRELUDE SNAP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 18586402
• Report Number: 18586402
• Device Sequence Number: 8517938
• Product Code: DYB
• UDI-Device Identifier: 00884450467954
• UDI-Public: (01)00884450467954(17)270724(10)12734683
• 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): 01/17/2024
• Report Date (Section F): 01/17/2024

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: 10884450467951
• Device Catalogue Number: PLS-1006/A
• Device Lot Number: 12734683
• 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: 01/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 162 KG
• Date Report Sent to FDA: 01/17/2024