MAUDE Adverse Event Report: Datascope Corp. SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet); System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0576-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the sensation plus 50cc balloon catheter, the cardiosave pump generated a gas loss alarm, causing the intra-aortic balloon pump (iabp) therapy to stop.Intra-aortic balloon (iab) fill was done by pressing iab refill and therapy was restarted; however, the issue recurred.The iab catheter was inspected, and no signs of perforation were observed.No blood was detected in the helium line.The helium tank was confirmed to be adequately filled and not empty.All system connections were checked and found to be secure.The patient was not tachycardic or febrile at the time of the event.No harm to the patient reported.The alarm occurred during the night before and morning of the (b)(6).The balloon pump was exchanged for a new machine on the night shift.Second pump also generated a gas loss alarm.The details of the first pump are not available.A getinge filed service engineer (fse) was dispatched to evaluate the iabp used as a second unit.Fse confirmed gas loss alarms in logs.No other errors or leak were noted.
Additional Manufacturer Narrative
Event site telephone: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)
• 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: 50472651
• Report Number: 2248146-2026-0001460
• Device Sequence Number: 16001924
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000468926(17)280411(11)250411
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000468926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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: Cardiosave (b)(6), Cardiosave (b)(6)
• Patient Sex: Unknown
• Patient Weight: 143 LB