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

Model Number	10884450467982
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Early 90¿s female with history of sick sinus syndrome.Procedure: dual chamber permanent pacemaker implant.When the device was removed from packaging, the sheath was observed to not be tapered at the tip.Unable to use 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 parkway; south jordan UT 84095
• MDR Report Key: 15485010
• Report Number: 15485010
• Device Sequence Number: 12795318
• Product Code: DYB
• UDI-Device Identifier: 00884450467985
• UDI-Public: (01)00884450467985(01)00884450467985(17)260621(10)2440517
• 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): 09/09/2022
• Report Date (Section F): 09/09/2022

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: 10884450467982
• Device Catalogue Number: PLS-1007/A
• Device Lot Number: 2440517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 46 KG
• Date Report Sent to FDA: 09/09/2022