MAUDE Adverse Event Report: Datascope Corp. Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0568-01U
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, through the emergency support program call, a fiber-optic sensor failure during use with an axillary-placed sensation plus 7.5fr.40cc intra-aortic balloon (iab).The fiber-optic cable was not initially connected to the cardiosave, and the pump did not recognize the fiber-optic connection after reconnection; however, the same cable was recognized when connected to a second cardiosave.After the cable was reconnected to the original pump, a fiber-optic sensor failure alarm occurred, indicating an issue with the fiber-optic sensor associated with the iab catheter.The fiber-optic sensor was labeled "do not use - fiber optic sensor failure," arterial pressure monitoring was resumed through the transduced inner lumen with appropriate readings.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Initial reporter: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only
• 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: 50711569
• Report Number: 2248146-2026-0001518
• Device Sequence Number: 13408325
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000492216
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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 (IABP).
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 178 LB