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 Codes	Inappropriate Waveform (2536); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by direct call from the customer to the emergency support program, that during use of sensation plus 50cc balloon catheter a fiber optic sensor failure alarm occurred on cardiosave display with loss of the fiber optic signal and no a/p waveform displayed.The clinician confirmed there were no visible kinks in the fo cable and reinserted the cable correctly (red arrow to red arrow), but the alarm recurred.The patient had recently arrived from the or following iabp placement.The user was instructed to transition from fo monitoring to a transduced pressure source and to coil, label, and remove the fo cable from use.Ifu recommendations regarding pressure bag positioning and maintenance of inner lumen patency were also reviewed.No harm to the patient reported.
Additional Manufacturer Narrative
Contact person name: (b)(6).  iab sensor failure: malfunction or signal loss from the fiber optic pressure sensor in an intra-aortic balloon catheter, critical for accurate pressure waveform and pump timing.  a sensor failure can occur due to one or more of the following probable causes: optical sensor kink.Break in sensor.Connector issue.  difficult or unable to monitor arterial pressure is a condition in which the intra-aortic balloon pump (iabp) cannot obtain a reliable arterial pressure waveform due to issues such as sensor failure (fiber-optic iab calibration failure or disconnection and/or fiber optic break), catheter lumen obstruction (e.G., clot, kink, or lumen damage), setup or equipment problems (e.G., improper zeroing, air bubbles, damping, loose connections), or patient-related factors, like low pulse pressure or arrhythmias.In these situations, the arterial signal becomes inaccurate or unusable for safe iabp operation.  the difficult or unable to monitor arterial pressure can occur due to one or more of the following factors: blood clot (thrombus) formation within the inner lumen.A break in the inner lumen.A kink in the inner lumen.Fiber-optic iab calibration failure or disconnection.Fiber optic cable break.Fiber optic cable kink.Transducer not zeroed or vented properly.Over-damped or flat arterial pressure waveform due to bubbles or excessive tubing compliance.Loose or incorrect pressure cable connections.Patient condition (low pulse pressure, arrhythmias).Off-label use.  these conditions may promote a slow, dampened arterial pressure, leading to an inability to monitor the arterial pressure.Once any of the factors above take place, the user will no longer be able to transmit accurate arterial pressure waveforms.  this issue continues to be monitored within the manufacturer's quality system.

• 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: 50894947
• Report Number: 2248146-2026-0001569
• Device Sequence Number: 17618151
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: (01)10607567109633(10)3000518873(17)281212(11)251212
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 09/25/2026

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: 3000518873
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 165 LB