MAUDE Adverse Event Report: Datascope Corp. Sensation Plus 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0576-01U
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, the customer reported a fiber-optic sensor failure alarm on a cardiosave intra-aortic balloon pump (iabp) supporting a patient with a sensation plus 50cc intra-aortic balloon catheter.Troubleshooting, including disconnecting and reconnecting the fiber-optic cable, was unsuccessful; the customer was instructed to disconnect the fiber-optic cable and continue therapy using the transduced inner lumen arterial pressure source, which was already connected and zeroed.No harm was reported.No further assistance was required.The customer requested an iab catheter return kit.A return kit was sent, but it later returned to the manufacturer without the catheter.
Event or Problem Description
During an emergency support program call, the customer reported a fiber optic sensor failure alarm on a cardiosave intra aortic balloon pump (iabp) supporting a patient with a sensation plus 50cc intra aortic balloon catheter.Nurse stated they have attempted troubleshooting but cannot get the fo ap tracing.Disconnecting and reconnection of the fo plug is unsuccessful in regaining the signal.Esp personnel reviewed disconnecting and not reconnecting the fo plug so the alarm would no longer persist.The inner lumen is connected to the cardiosave, a transduced ap is already present and zeroed.Emily states the iab was placed and is a femoral insertion.Emily has no further questions or concerns for me and states appreciation of getting the alarm to stop.She gives the product surveillance and shipping information for an iab catheter return kit to be sent.No harm injury was reported.
Additional Manufacturer Narrative
E1 - event site name: (b)(6) medical center.Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Updated field: b4,b5,b6, b7,d9,g3, g6, g7, h2, h3, h6(type of investigation, investigation findings, investigation conclusions, component codes), h11 corrected field: d4(udi), revert d8 field, should be blank, product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, a iab sensor failure can occur due to one or more of the following probable causes.Iab sensor failure: a fiber optic sensor failure in an intra aortic balloon refers to the malfunction or loss of signal from the fiber optic pressure sensor within the intra aortic balloon catheter.This sensor is responsible for accurately detecting and transmitting real-time aortic pressure waveforms to the iabp console, which are critical for timing the inflation and deflation of the balloon during cardiac cycles.Causes of a sensor failure: a sensor failure can result from the following optical sensor kink.Break in sensor.Connector issue.

• Brand Name: Sensation Plus 8Fr. 50cc 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: 50079244
• Report Number: 2248146-2026-0001342
• Device Sequence Number: 21395722
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: (01)10607567109633(10)3000525520(17)290202(11)260202
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2026

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: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000525520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/14/2026; 09/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/27/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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 IABP
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 268 LB