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

Catalog Number	0684-00-0293
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after approximately seven hours of intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) generated a leak in iab circuit alarm and stopped therapy.There was a slow helium leak.The customer confirmed that the iab was leaking as the same issue occurred when it was connected to another iabp.Therapy was concluded after 12 hours.There was no patient harm or adverse event reported.This report is for the iab involved in the event.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-01661.
Additional Manufacturer Narrative
Initial reporter occupation: clinical manager.Initial reporter: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17773910
• Report Number: 2248146-2023-00578
• Device Sequence Number: 12375704
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 06/06/2024
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000175189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2021
• 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: CARDIOSAVE / (B)(6)
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 96 KG