MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BASIXCOMPAK¿; CATHETER-BALLOON INFLATOR, SINGLE-USE

Catalog Number	IN4130/T
Medical Device Problem Codes	Inflation Problem (1310); Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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 the process of inflation, the handle was found to detach and became disconnected from the device.The device was reassembled to complete the procedure.No patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned; an evaluation was performed.The complaint was confirmed, and the root cause was determined to be lack of adhesive placement during assembly.A 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.

• Brand Name: BASIXCOMPAK¿
• Common Device Name: CATHETER-BALLOON INFLATOR, SINGLE-USE
• 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: 23810385
• Report Number: 1721504-2025-00719
• Device Sequence Number: 13101387
• Product Code: PTM
• UDI-Device Identifier: 00884450860953
• UDI-Public: 00884450860953
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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
• Device Catalogue Number: IN4130/T
• Device Lot Number: I3161177
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown