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

Catalog Number	PLS-1007/A
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
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 they experienced problems while splitting and peeling the sheath.The material of the sheath wasn't firm/solid enough to be split completely.When they split the sheath it 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.No patient injury reported.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.According to the findings from the returned unit, the issue was related to incomplete scoring on the sheath tubing.The scoring process is a critical operation that must be performed using validated machine parameters and verified through visual inspection.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PRELUDE SNAP SPLITTABLE SHEATH INTRODUCER
• 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 MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22099412
• Report Number: 3011642792-2025-00093
• Device Sequence Number: 20963980
• 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): 05/28/2025

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: I13139549
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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