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

Catalog Number	SDRB-REG-LT/B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during use of the device the pressure balloon of the radial artery band was found to be leaking.No patient injury to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted when the evaluation is complete.
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 search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint could not be confirmed as the device functioned as intended.The event reported by the customer could not be replicated.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.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 cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 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: 23697704
• Report Number: 1721504-2025-00686
• Device Sequence Number: 21426580
• Product Code: DXC
• UDI-Device Identifier: 00884450574416
• UDI-Public: 00884450574416
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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
• Operator of Device: Health Professional
• Device Catalogue Number: SDRB-REG-LT/B
• Device Lot Number: I3187890
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/14/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown