MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BASIXCOMPAK¿; ANGIOGRAPHIC INJECTOR AND SYRINGE

Catalog Number	IN4352/K
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
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
Our angiography department has encountered a problem with the merit inflator reference in4352.On (b)(6) 2025, the inflator handle ended up in the nurse's hand.No patient details or injury was reported.Hospital angiography department reports placing the batch on quarantine.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.On inspection, under magnification the o ring was not seated properly leaving a gap between the gauge and the barrel.This complaint is confirmed.The root cause is misalignment of the o-ring during assembly.A search of the complaint database was performed and one similar complaint for this lot number was found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the engineering, quality, and management team members.
Event or Problem Description
Additional information was received in a meeting on 15oct2025.The france team confirmed they had an inability to deflate balloon occur on one unit during a coronary angioplasty of the left coronary trunk.The handle stayed attached but would not deflate.They were able to use another inflator, and the patient suffered no harm.

• Brand Name: BASIXCOMPAK¿
• Common Device Name: ANGIOGRAPHIC INJECTOR AND SYRINGE
• 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
• MDR Report Key: 22952880
• Report Number: 1721504-2025-00327
• Device Sequence Number: 9894040
• Product Code: PTM
• UDI-Device Identifier: 00884450638347
• UDI-Public: 00884450638347
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: IN4352/K
• Device Lot Number: I3129673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Patient Sex: Unknown