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	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that gas loss alarm occured on a cardiosave intra-aortic balloon pump (iabp) during support with a sensation plus 50cc intra-aortic balloon (iab) catheter for left ventricular (lv) assist following surgery.Approximately six hours after insertion, while the patient was in the intensive care unit (icu), a gas loss alarm occurred.No blood was observed in the helium tubing.Iabp therapy was discontinued and the iab catheter was removed.No patient harm or injury was reported.
Additional Manufacturer Narrative
Event site postal code: 4818 ck.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: 50800364
• Report Number: 2248146-2026-0001542
• Device Sequence Number: 8643648
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 3000497717
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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 Intra-Aortic Balloon Pump OT1612103
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 151 LB