MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDESYNC¿.RADIAL COMPRESSION DEVICE; CLAMP, VASCULAR

Catalog Number	SRB24MED
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/12/2025
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.
Event or Problem Description
The account alleges that during a radial access procedure, the physician tried to use two different merit radial compression devices.Air was leaking back out of the device, and there was not enough pressure to close the radial artery access site.The patient developed a large hematoma and was admitted overnight for observation.

• Brand Name: PRELUDESYNC¿.RADIAL COMPRESSION DEVICE
• Common Device Name: CLAMP, VASCULAR
• 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: 23658625
• Report Number: 1721504-2025-00642
• Device Sequence Number: 10055103
• Product Code: DXC
• UDI-Device Identifier: 10884450286880
• UDI-Public: 10884450286880
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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?: Yes
• Device Catalogue Number: SRB24MED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown