MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5 FR. 40CC IAB (CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0295-05
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, mega 40cc intra-aortic balloon (iab) malfunctioned.The device displayed alarm regarding gas leak in iab circuit.A new intra-aortic balloon was successfully used.There was patient harm or injury reported.
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6) event site telephone: (b)(6).Gas loss in iab circuit: helium loss due to leak or diffusion.Alarm triggers if loss is greater than 5 cc per hour.Conditions: inflation 80 ms or greater.Deflation 250 ms or greater.Causes: 1.Leak or blood in catheter balloon tubing 2.Kinks or occlusions.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9 (device available for eval), g3, g6, h2, h3, h11 corrected fields: d4 (lot #, udi #), d10, h6 (type of investigation) revert the contents of section e1 (event site postal code) to blank.It was reported that during use, the mega 40cc intra aortic balloon (iab) malfunctioned, with the device generating an alarm indicating a gas leak in the iab circuit.The balloon was replaced, and a new intra aortic balloon was successfully used.A patient was involved in the event; however, no patient harm was reported.The indication for therapy was cardiogenic shock (cgs).The iab was inserted on (b)(6) 2026 and remained in use for approximately 30 minutes.Information regarding the initial attempt to remove the catheter and the exact time of therapy discontinuation is unavailable.

• Brand Name: MEGA 7.5 FR. 40CC IAB (CHINA)
• 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: 24798585
• Report Number: 2248146-2026-0000859
• Device Sequence Number: 13134699
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(10)3000490843(17)280604(11)250604
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0295-05
• Device Lot Number: 3000490843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CARDIOSAVE.; UNKNOWN.
• Patient Sex: Female
• Patient Weight: 80 KG