MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fiberoptic sensor failure occurred on a cardiosave intra aortic balloon pump during active therapy, resulting in loss of arterial pressure waveform via fiberoptics.Therapy was continued using pressure monitoring via the inner lumen.Troubleshooting identified excess pressure tubing and setup issues contributing to signal problems.After correction, waveform quality improved and alarms resolved.Iab sensor failure refers to malfunction or signal loss from the fiber optic pressure sensor in an intra aortic balloon catheter, which is critical for accurate pressure waveform and pump timing.Causes of sensor failure a sensor failure can result from the following 1 optical sensor kink 2 break in sensor 3 connector issue effects are as follows 1 loss or poor waveform 2 calibration or alarm errors 3 pump unable to detect sensor.
Event or Problem Description
(b)(6), cvicu rn, called into the emergency support program line to request support with a fiberoptic sensor failure on a cardiosave.She was unable to obtain an a/p waveform and switched to transducing the inner lumen.Esp personnel instructed her to coil and label the fiberoptic cable do not use.Pump bp was 59/50 with an unable to update timing alarm active.Troubleshooting identified excess pressure tubing, which was removed.(b)(6) aspirated and flushed the lumen, and proper setup was reinforced.The waveform improved and the alarm resolved, though pulse pressure remained narrow (map 64).Comparison showed radial a/p 75/61 and pump a/p 66/58.Image review indicated elevated heart rate, narrow pulse pressure, and augmentation 10 above systolic bp.X ray showed the marker below the 2nd and 3rd intercostal space.Esp personnel advised provider consultation for clinical management and balloon placement evaluation.No harm or injury to the patient was reported.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• 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: 25197237
• Report Number: 2248146-2026-0001025
• Device Sequence Number: 18669565
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000513355(17)281112(11)251112
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000513355
• 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: 04/25/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 64 KG