MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE®; VASCULAR DILATOR, SINGLE-USE

Catalog Number	PSI-5F-11-035-18G/D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Unintended Loss of Vascular Access (4867)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
A published clinical study describing use of the merit prelude sheath introducers alleges that patients experienced multiple complications acute thrombosis/dissection,arterial access complications, groin hematoma, groin infection, pseudoaneurysm, stent occlusions, and major amputations.No explicit prelude sheath malfunction was identified; events represent vascular and access-site complications occurring in the setting of device use.

• Brand Name: PRELUDE®
• Common Device Name: VASCULAR DILATOR, SINGLE-USE
• 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: 23810435
• Report Number: 1721504-2025-00721
• Device Sequence Number: 12689605
• Product Code: DRE
• UDI-Device Identifier: 00884450615102
• UDI-Public: 00884450615102
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: PSI-5F-11-035-18G/D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown