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

Catalog Number	PRO-5F-11-035/F
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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 during the procedures while inserting the guide wire through the sheath, the wire protruded from the sheath into the patient.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation; a photo was provided and additional unopened samples from the same lot number were returned.Based on the image, the wire was observed exiting the sheath tube, confirming damage.Twenty sample units were also evaluated.During the evaluation, visual and tactile inspections were performed on the sheath tubing and holster area.No irregularities were observed in the returned units.A search of the complaint database was performed and no similar complaint for this lot number was found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.

• Brand Name: PRELUDE® PRO SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• 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: 22650588
• Report Number: 1721504-2025-00192
• Device Sequence Number: 21032228
• Product Code: DRE
• UDI-Device Identifier: 00884450707326
• UDI-Public: 00884450707326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: PRO-5F-11-035/F
• Device Lot Number: H3208448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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