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); Off-Label Use (1494); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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 record id #(b)(4).
Event or Problem Description
Customer called to report that while using intra-aortic balloon, the a-line is not reading properly.It occurred during use and no patient harm or injury reported.Customer also stated the balloon was axillary.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: g2.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected fields: d10, h6 (medical device problem code).G4.(pma 510k): the 510k code is left blank because it is unavailable.No decon or visual inspection performed since product was not returned and could not be evaluated.A nurse contacted the emergency support line due to an issue with an a-line not reading properly.During the call, it was revealed that the balloon was positioned axillary.The support agent informed the nurse that vamp use is not recommended by getinge.After troubleshooting according to the instructions for use (ifu), the arterial waveform improved significantly.The damped arterial waveform due to improper line maintenance and use of non-recommended aspiration method (vamp), compounded by axillary balloon placement.Based on the event description, the root cause has been identified as user error.There was no malfunction of the iab; rather, the customer required assistance to navigate the proper use of the device.The navigation provided was not in response to an issue or failure, but solely to guide the healthcare provider in operating the iab correctly.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. 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: 22563302
• Report Number: 2248146-2025-0000409
• Device Sequence Number: 15764798
• Product Code: DSP
• UDI-Device Identifier: 10607567107950
• UDI-Public: (01)10607567107950(10)3000396585(17)270613(11)240613
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2025

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: 0684-00-0294-01
• Device Catalogue Number: 0684-00-0294-01
• Device Lot Number: 3000396585
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 09/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/25/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: INTRA-AORTIC BALLOON PUMP (IABP)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG