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); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6) hospital.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 record id: (b)(4).
Event or Problem Description
It was reported by the customer on (b)(6) 2025 that the bleeding was found in the intra-aortic balloon (iab) catheter, suggesting a ruptured iabp pump balloon.Counterpulsation was immediately stopped, the machine was placed in standby mode, and the iabp pump was quickly removed.Pressure was applied to the puncture site for 15 minutes, followed by pressure bandaging with gauze.Investigation revealed that the catheter inside the iabp pump balloon had ruptured, causing balloon perforation and a small amount of thrombus formation within the balloon.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11 based on the description, on (b)(6) 2025 at 00:12, the patient¿s iabp waveform suddenly changed, showing a sharp drop in counter pulsation pressure, triggering an alarm.Inspection revealed blood in the catheter, indicating a balloon rupture.Counter pulsation was stopped, the pump was removed immediately, and the puncture site was compressed and bandaged.The rupture was caused by a catheter break inside the balloon, with minor thrombus formation.Thanks to prompt removal, the patient remained stable with no life threatening complications.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.
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: 24159332
• Report Number: 2248146-2026-0000519
• Device Sequence Number: 9112250
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(10)3000485195(17)280623(11)250623
• 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): 02/23/2026

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: 3000485195
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 02/21/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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 PUMP.
• Patient Age: 55 YR
• Patient Sex: Female