MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0294-01
Medical Device Problem Codes	Pacing Problem (1439); Obstruction of Flow (2423); Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
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 record id: (b)(4).
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra aortic balloon (iab) mega 30cch had difficult/ unable to monitor waveform & clotted lumen.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: h6 (medical device problem code, investigation findings, component codes, investigation conclusions) keeping g4 field blank as data is not available.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:b4,g3,g6,h2,h6(type of investigation, investigation findings,component code,conclusion),h11.Nurse called requesting assistance with obtaining an arterial waveform after placing a balloon pump.The pump displayed arterial pressures greater than three hundred over three hundred and although the line was flushed aspiration was unsuccessful.It was explained that the inner lumen was likely clotted and recommendations were given to either place a radial arterial line or replace the catheter while still in the cath lab.Guidance was provided on flushing the inner lumen after aspiration during insertion and capping the inner lumen if an alternate arterial line was used.The nurse later confirmed they would replace the intra aortic balloon catheter.Additional questions regarding pressure bag fluids and anticoagulation targets were addressed and it was clarified that these decisions follow physician or hospital policy and that the balloon should not remain immobile for more than thirty minutes.

• Brand Name: MEGA 7.5FR. 30CC IAB
• 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: 24637038
• Report Number: 2248146-2026-0000790
• Device Sequence Number: 10070020
• Product Code: DSP
• UDI-Device Identifier: 10607567107950
• UDI-Public: (01)10607567107950(10)3000508953(17)281022(11)251022
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 0684-00-0294-01
• Device Catalogue Number: 0684-00-0294-01
• Device Lot Number: 3000508953
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/03/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 67 KG