MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO PRELUDE SNAP; SPLITTABLE SHEATH INTRODUCER

Catalog Number	PLS-1007/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the material of the sheath wasn't firm/solid enough to be split completely but was ragged/broke so they had to slice the wall with a knife/scissor to be able to remove the sheath and complete the procedure.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and functional tests were performed.The complaint is confirmed.Root cause is attributed to the manufacturing process.A review of the device history record was performed and one exception document was found.A review of the complaint database was performed and no similar complaints for this lot number were identified.Corrective actions are in process.

• Brand Name: PRELUDE SNAP
• Common Device Name: SPLITTABLE SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22286384
• Report Number: 1721504-2025-00094
• Device Sequence Number: 8930110
• Product Code: DYB
• UDI-Device Identifier: 00884450467985
• UDI-Public: 00884450467985
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Catalogue Number: PLS-1007/A
• Device Lot Number: I3161012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown