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	Leak/Splash (1354); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
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 physician requested assistance with waveform interpretation issues and multiple gas loss alarms during cardiosave therapy following coronary artery bypass grafting.Troubleshooting included ecg electrode replacement, fo cable recalibration, and lumen patency verification, resulting in improved signal quality and stable pressure monitoring.No blood was observed in the helium tubing, the alarms were considered likely related to the patient's postoperative condition.No patient harm was reported.
Additional Manufacturer Narrative
The parent investigation evaluated cardiosave gas loss alarms involving the iab circuit due to patient conditions.A gas loss alarm is activated when cumulative helium loss exceeds 5 cc relative to the last autofill volume.The alarm requires an iab inflation period of at least 80 milliseconds and a deflation period of at least 250 milliseconds, may occur in all operating modes, and results in system venting and iab deflation.Gas loss may be associated with patient conditions such as fever or tachycardia.Based on the available information, no iab or iabp malfunction was identified through this parent investigation.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, including fiber optic iab calibration failure, disconnection, or fiber optic break; catheter lumen obstruction, such as clot, kink, or lumen damage; setup or equipment problems, such as improper zeroing, air bubbles, damping, or loose connections; or patient related factors such as low pulse pressure or arrhythmias.In these situations, the arterial signal becomes inaccurate or unusable for safe iabp operation.The issue is being addressed through corrective and preventive actions.

• 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: 50797917
• Report Number: 2248146-2026-0001533
• Device Sequence Number: 16094900
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Cardiosave Intra-Aortic Balloon Pump (b)(4)
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 162 LB