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

Catalog Number	IN4130/JPH
Medical Device Problem Codes	Inflation Problem (1310); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was found to fail due to incorrect placement of the adhesive in the bond between the plunger and the handle cap.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.Non-conformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
The account alleges that during a shunt percutaneous transluminal angioplasty (pta) procedure, vascular dilation was performed using a kaneka pta balloon.The balloon was pressurized to 30 atm on two occasions without issue.During the third pressurization, a popping sound was reported, and the pressure gauge reading dropped to 0 atm.The plunger remained engaged and did not retract.The operator then depressurized the device by grasping the lock/release bar and pulling the plunger handle.The procedure was completed using another balloon of the same part number and lot.The procedure was completed without reported patient complications.

• 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: 23791676
• Report Number: 1721504-2025-00714
• Device Sequence Number: 18765278
• Product Code: PTM
• UDI-Device Identifier: 00884450498538
• UDI-Public: 00884450498538
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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/JPH
• Device Lot Number: I3232041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown