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

Model Number	0684-00-0295-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a leak occurred and blood was noted inside the tubing.It was noted that the patient was on heart lung machine (hlm).While clamping the aorta, the surgeon damaged the iab.The iab was tested by starting with an internal trigger (standard during hlm) and it was determined that the iab was damaged.The customer checked the tube and pulled it.The iab was removed.The alarm log of the cardiosave intra-aortic balloon pump (iabp) noted a gas loss in iab circuit alarm.There was no patient harm or adverse event reported.This report is for the iab involved in this event.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-03782.
Additional Manufacturer Narrative
Event site full name: (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).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # (b)(4).
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.Udi # is incomplete as the lot #, manufacture date, exp.Date were not provided.Four gfe attempts were made to obtain this information without success.Complaint record id # (b)(4).

• Brand Name: MEGA 7.5FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18107927
• Report Number: 2248146-2023-00664
• Device Sequence Number: 12263059
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)UNKNOWN(17)UNKNOWN(11)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/26/2024

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 Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0295-01
• Device Lot Number: UNKNOWN - DISCARDED
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 08/26/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/12/2023; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 / CH264628J7.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 89 KG