MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE ACT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
With four different packages of product, the dilator would not advance all the way into the sheath.We cannot tell by looking it, but either the dilator is too big to advance, or the sheath is too small to allow the dilator to advance.Sheaths come in french sizes.The dilator and sheath in these four instances should all be 8f.Therefore, either the dilator is larger than 8f or the sheath is smaller than 8f.However, both the dilator and sheath were labeled as 8f (blue).Either the dilator is too big, or the sheath is too small.Packaging only saved once (for this report), but happened with 3 previous times.

• Brand Name: PRELUDE ACT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 20693678
• Report Number: 20693678
• Device Sequence Number: 8584448
• Product Code: DRE
• UDI-Device Identifier: 00884450709115
• UDI-Public: (01)00884450709115
• 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): 10/31/2024
• Report Date (Section F): 10/31/2024

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: F
• Device Catalogue Number: PSI-8F-11-038ACT
• Device Lot Number: H2980852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• 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 Age: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 10/31/2024