MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE IDEAL¿; VASCULAR CATHETER INTRODUCTION KIT, NON-STEERABLE

Catalog Number	PID5F11018SS/H
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
It was reported that part of the sheath tip was found to be broken after completion of the procedure when removing the sheath.The sheath was used for pedal access.Several wires and balloons were introduced through the sheath.No patient injury.
Additional Manufacturer Narrative
The suspect device was partially returned for evaluation.The failure as reported was observed via a picture provided.Upon evaluation, the returned device passed functionality tests and functioned as expected.The root cause can not be determined.A search of the complaint database was performed and 1 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 engineering, quality, and management team members.

• Brand Name: PRELUDE IDEAL¿
• Common Device Name: VASCULAR CATHETER INTRODUCTION KIT, NON-STEERABLE
• 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 ; 8012084225
• MDR Report Key: 25033733
• Report Number: 1721504-2026-00026
• Device Sequence Number: 18372730
• Product Code: DYB
• UDI-Device Identifier: 00884450114674
• UDI-Public: 00884450114674
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173750
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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
• Device Catalogue Number: PID5F11018SS/H
• Device Lot Number: H3366709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown