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 Codes	Inappropriate Waveform (2536); Device Sensing Problem (2917); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, e1, g3, g6, h2, h11\ correction fields: b1, d10, g7, h6(type of investigation, investigation findings, investigation conclusions), please revert a1 and d8 to blank as these details were sent inadvertently in initial report.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Event site name: (b)(6).\ \ difficult/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, disconnection, or fiber optic cable break), catheter lumen obstruction (e.G., clot, kink, or lumen damage), setup or equipment problems (e.G., improper zeroing, air bubbles, damping, or loose connections), or patient-related factors such as low pulse pressure or arrhythmias.In these situations, the arterial pressure signal may become inaccurate or unavailable for safe iabp operation.\ difficult/unable to monitor arterial pressure can occur due to one or more of the following factors:\ - blood clot (thrombus) formation within the inner lumen,\ - break in the inner lumen,\ - kink in the inner lumen,\ - fiber optic iab calibration failure or disconnection,\ - fiber optic cable break,\ - fiber optic cable kink,\ - transducer not properly zeroed or vented,\ - overdamped or flat arterial pressure waveform due to air bubbles or excessive tubing compliance,\ - loose or incorrect pressure cable connections,\ - off-label use.\  \ a sensor failure can occur due to one or more of the following probable causes:\ - optical sensor kink,\ - break in the sensor,\ - connector issue.\ \ this issue continues to be monitored within the manufacturer's quality system.
Event or Problem Description
It was reported by direct call from the customer to the emergency support program, that during use of sensation plus 40cc balloon catheter a poor-quality arterial waveform on the iabp monitor while using the fiberoptix (fo) signal as the ap source.The fo arterial waveform displayed a whip-like artifact with pressure readings of 52/20 mmhg (map 44) and augmentation of 62.Comparison with the bedside monitor using the radial arterial line showed stable pressures of 104/61 mmhg (map 80).Troubleshooting, including multiple flushes of the inner lumen, did not resolve the waveform artifact.Review of a chest x-ray confirmed the distal radiopaque marker was positioned between the 2nd and 3rd intercostal spaces.Technical support recommended switching the ap source from fo to the transducer and guided the clinician through the process.Following the change, appropriate arterial waveforms and pressure values were obtained.No patient harm or injury was reported.

• 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: 50816169
• Report Number: 2248146-2026-0001549
• Device Sequence Number: 10218612
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565(10)3000526761(17)290205(11)260205
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/18/2026

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: 3000526761
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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: Unknown IABP.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 207 LB