MAUDE Adverse Event Report: Merit Medical Systems, Inc. PreludeSYNC¿; Radial artery compression device

Catalog Number	SRB24AC/CNB
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• Brand Name: PreludeSYNC¿
• Common Device Name: Radial artery compression device
• 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: lisa perz msn rn pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50950763
• Report Number: 1721504-2026-00479
• Device Sequence Number: 9552205
• Product Code: DXC
• UDI-Device Identifier: 00884450567784
• UDI-Public: 00884450567784
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K162988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: SRB24AC/CNB
• Device Lot Number: I3505639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown