MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nurse reported intermittent damping of the arterial waveform and episodes where the balloon waveform flattened for about ten seconds along with an unusual arterial peak during balloon inflation.Initial troubleshooting involved reviewing a screenshot which showed acceptable numeric values with mild artifact and a notch in the arterial waveform suggesting possible signal distortion.The nurse was guided to transduce the inner lumen but observed a very damp waveform and was unable to aspirate blood which indicated the inner lumen was likely clotted.To resolve this the inner lumen was identified as unusable and the nurse was instructed to cap it immediately disconnect and discard the attached tubing and clearly label the lumen as do not use due to thrombus risk.Education was provided on proper line maintenance to prevent recurrence.Placement verification was recommended using chest x ray to ensure the balloon tip was positioned correctly between the second and third intercostal space.Because the inner lumen was clotted and there was artifact in the fiber optic signal it was determined that an alternate arterial pressure source would be required for accurate balloon timing.Later screenshots showed a flat balloon waveform with an autofilling and zeroing message.This was explained as a normal function where the pump performs periodic helium refill and calibration every two hours which can temporarily interrupt the waveform display.The nurse confirmed the physician verified correct balloon placement and decided not to place an arterial line since the device would be removed shortly for surgery.The issue was managed by identifying the clotted lumen removing it from use understanding the normal pump autofill behavior and continuing therapy using available signals until device removal.
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra aortic balloon (iab) sensation plus 40cc had a clotted inner lumen.There were no patient harm or injury was reported.

• Brand Name: SENSATION 7FR. 40CC IAB
• 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: 25197882
• Report Number: 2248146-2026-0001030
• Device Sequence Number: 10110445
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000451921(17)280218(11)250218
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• 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): 05/18/2026

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000451921
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: IABP
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG