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); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint id# (b)(4).
Event or Problem Description
It reported that during intra-aortic balloon (iab) therapy, the balloon ruptured and bleeding into the intubation.No injuries occurred.
Additional Manufacturer Narrative
Updated fields: b3, b4, d1 (brand name), d4 (version or model #, catalog #, lot #, exp.Date, unique identifier (udi) #), g3, g4, g6, h2, h4 (manufacture date), h11.Corrected fields: h6 (medical device ¿ problem code), g2.
Additional Manufacturer Narrative
Updated fields: b4, e1 (event site email), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.Due to character limit in block e1 full event site name and address are (b)(6).After inspection, the cs100 iabp device was found to have no abnormalities, and all indicators passed successfully.The device was functioning correctly.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.

• 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: 23607227
• Report Number: 2248146-2025-0000753
• Device Sequence Number: 13221858
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(10)3000453449(17)280212(11)250212
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2026

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: 3000453449
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 01/23/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/26/2025; 01/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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: CS100
• Patient Sex: Unknown