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

Catalog Number	SRB24AC/B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during use the balloon of the radial band leaked and was unusable.Another device was used to complete the procedure.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The failure as reported was observed.During the evaluation a wrinkle/pinch was observed on the balloon of the device.The device was then submerged in water, and inflated with the 20ml associated syringe.A leak was immediately observed coming from the pinhole near the center of the balloon.During the manufacturing process all devices undergo leak testing to ensure there are no leaks, and visually inspected for wrinkles prior to final release.Since the packaging was opened at the customer site, it is not possible to determine with certainty when the damage occurred, and the root cause of the damage to the balloon could not be determined.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: PRELUDESYNC DISTAL¿
• Common Device Name: RADIAL ARTERY COMPRESSION DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23810591
• Report Number: 1721504-2025-00735
• Device Sequence Number: 15799993
• Product Code: DXC
• UDI-Device Identifier: 00884450567784
• UDI-Public: 00884450567784
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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/B
• Device Lot Number: I3031279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown