MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO PRELUDESYNC EVO RADIAL COMPRESSION DEVICE

Catalog Number	SRB29LBAC/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pseudoaneurysm (2605)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the complaint database and device history record cannot be performed as a lot number was not provided.
Event or Problem Description
The account alleges that they experienced issues when using the sync evo band, resulting in several hematomas that led to pseudoaneurysms that required surgical intervention to repair.The physician was not sure how the evo band contributed to the patient's injury but did confirm that they are using the stat seal product on all radial procedures with 1 hour recovery times along with the sync evo band.

• Brand Name: PRELUDESYNC EVO RADIAL COMPRESSION DEVICE
• Common Device Name: RADIAL COMPRESSION DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 21989451
• Report Number: 3011642792-2025-00061
• Device Sequence Number: 15531987
• Product Code: DXC
• UDI-Device Identifier: 00884450567876
• UDI-Public: 00884450567876
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: SRB29LBAC/B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STAT SEAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown