MAUDE Adverse Event Report: Datascope Corp. MEGA 7.5Fr. 40cc IAB with Accessories (APA), US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0295-02U
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.Initial reporter: initial reporter: (b)(6).Event site name: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the customer that during use of mega 40cc intra-aortic balloon (iab) catheter blood was observed in the helium line on (b)(6) 2026 at approximately 08:00.The patient was ambulatory on a daily basis during therapy.Approximately 11 days after insertion, a small subcutaneous hematoma near the insertion site was documented.No additional issues were reported prior to the rupture event.Following identification of blood in the helium tubing, the catheter was removed on (b)(6) 2026 at 08:00.Total dwell time was approximately 18 days, 11 hours, and 7 minutes.Catheter removal was completed without complication, and no adverse events associated with the removal procedure were reported.The balloon catheter was inserted via the left axillary artery in the catheterization laboratory.

• Brand Name: MEGA 7.5Fr. 40cc IAB with Accessories (APA), US Only
• Common Device Name: System, Balloon, Intra-Aortic And Control
• Manufacturer (Section D): Datascope Corp.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): Datascope Corp.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 50880396
• Report Number: 2248146-2026-0001564
• Device Sequence Number: 9826981
• Product Code: DSP
• UDI-Device Identifier: 10607567109602
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Model Number: 0684-00-0295-02U
• Device Catalogue Number: 0684-00-0295-02U
• Device Lot Number: 3000534620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AC3 Optimus console.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 162 LB