MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO BASIXCOMPAK INFLATION DEVICE

Catalog Number	IN4130/CNK
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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 a during inflations in a pci procedure the operator reported that the inflation device was leaking air and the balloon could not be inflated to the intended atms.A new inflation device was used to complete the procedure with no patient injury reported.
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.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Based on the findings, the complaint has been confirmed.The root cause of the complaint is likely attributed to the improper o-ring and gauge assembly a process performed by the operators.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.

• Brand Name: BASIXCOMPAK INFLATION DEVICE
• Common Device Name: INFLATION DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21976252
• Report Number: 3011642792-2025-00056
• Device Sequence Number: 9188230
• Product Code: PTM
• UDI-Device Identifier: 00884450637524
• UDI-Public: 00884450637524
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2025

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: IN4130/CNK
• Device Lot Number: I3074754
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 05/23/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/21/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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