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

Model Number	0684-00-0295-02
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Increase in Pressure (1491); Material Rupture (1546); Obstruction of Flow (2423); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Cardiomyopathy (1764); Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11 corrected field: d4 udi and lot no, h6 health effect clinical code, medical device problem code 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.
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- initial reporter: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that a balloon catheter intra-aortic balloon (iab) rupture occurred during overnight use of the iab catheter.The patient was ambulatory with left axillary insertion.Prior to the rupture, the system experienced repeated high pressure and kink alarms, volume reductions, and central lumen issues including dampening and clotting.The pump console was eventually exchanged, and the catheter was removed without complications.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b8 (other relevant history), e1 (event site city, event site state).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected field: h6 (medical device ¿ problem code).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation), h11.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter.The pressure tubing was also returned.Visual examination of the product detected the catheter tubing and inner lumen was completely separated within a kink approximately 0.3cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no other leaks were detected.The break found in the catheter tubing and inner lumen appears to have been the result of a severe kink, which eventually failed causing the reported problems.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.The evaluation confirmed the reported problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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.

• Brand Name: MEGA 7.5FR. 40CC IAB (WITH APA)
• 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: 23320616
• Report Number: 2249723-2025-0004355
• Device Sequence Number: 18775721
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: (01)10607567107981(10)3000282645(17)251127(11)221128
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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 Expiration Date: 11/27/2025
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0295-02
• Device Lot Number: 3000282645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 11/28/2025; 12/31/2025; 02/10/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/21/2025; 11/28/2025; 01/12/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: PUMP.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 126 KG