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 Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1: event site name: (b)(6) hospital.Event site telephone: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use o patient mega 40 cc intra aortic balloon (iab) after successful femoral artery puncture, the patient encountered difficulty in the process of balloon advancement.Eventually, the balloon was withdrawn and it was discovered that there was blood inside the balloon cavity.It was believed that the balloon had ruptured, so a new balloon was replaced.After the new balloon was replaced, it was successfully implanted and the equipment is operating normally.There was no harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, e1 (initial reporter), g3, g6, h2, h6 (investigation conclusions), h8, h11 corrected field d10.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g4 (pma/510k), g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.Corrected fields: d4 (lot and udi).After the femoral artery puncture was successfully performed, the patient encountered difficulty during the balloon advancement process.Upon withdrawing the balloon, it was discovered that blood had entered the balloon cavity, indicating a rupture.To resolve the issue, the ruptured balloon was replaced with a new one.The new balloon was successfully implanted, and the equipment is now operating normally.An intra-aortic balloon (iab) leak is the loss of integrity in the balloon membrane or its connections, allowing blood or gas to enter or escape.Causes: 1.User mishandling or not following ifu.2.Membrane folding or resistance.2.Patient-related factors (e.G., plaque abrasion).Impact: 1.Risk of gas embolism and patient injury.2.Suboptimal therapy or organ occlusion.3.Blood clot formation inside the balloon requiring surgical removal.Detection: 1.Pump leak alarms.2.Blood or fluid in tubing/membrane.3.Sudden waveform changes.4 resistance during catheter withdrawal.An intra-aortic balloon (iab) leak is the loss of integrity in the balloon membrane or its connections, allowing blood or gas to enter or escape.This can occur due to membrane stress (e.G., folding or resistance), patient-related factors such as plaque abrasion.
Event or Problem Description
N/a.

• 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: 23567039
• Report Number: 2248146-2025-0000727
• Device Sequence Number: 13313469
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(10)3000467657(17)280409(11)250409
• 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,Followup
• Report Date (Section B): 12/26/2025

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 Model Number: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0295-05
• Device Lot Number: 3000467657
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 12/26/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/26/2025; 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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: IABP
• Patient Age: 80 YR
• Patient Sex: Male