MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Due to character restrictions in block e1.Event site name: (b)(6) hospital.Event site state: (b)(6).A supplemental report will be submitted upon completion of our investigation.This complaint was opened as part of capa 1357192 to ensure the correct number of complaints are initiated for related events.Upon review of this complaint, an additional complaint was identified and opened, which was determined to be reportable.
Event or Problem Description
It was reported during intra-aortic balloon therapy that cardiosave intra-aortic balloon pump (iabp) has error message: autoload failed.The patient has died.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected field: h6 (health effect impact codes).Based on the event description, the patient was in critical condition, prompting a bedside iabp insertion.The balloon was placed without complications, but after initiating cycles, the device displayed persistent error messages despite following troubleshooting steps and restarting.Due to the risk posed by the balloon remaining inside, the physician removed it and proceeded with an ecmo procedure.The patient passed away within 24 hours of the event.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 in all iab risk files.All iab ifus address 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.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.Based on the rational provided above, no escalation to the capa process is required.
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 34CC 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: 23670141
• Report Number: 2248146-2025-0000784
• Device Sequence Number: 13188644
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041281
• 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
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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: CS300
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 62 KG