MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01
Medical Device Problem Codes	Restricted Flow rate (1248); Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra-aortic balloon (iab) sensation plus 40cch had a fiber optic waveform accuracy issue.There was some indication of restriction on the balloon waveform.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected field: h5.The complaint was received through a direct call from the customer to the emergency support program no harm or injury to the patient was reported a perfusionist called to request assistance with the fiber optic waveform she gave an overview of everything she had done prior to the call including unplugging and reconnecting the fiber optic.Esp team member reviewed a screenshot that showed a hr of 84 a transduced arterial pressure of 83/40 a mean of 83 and an augmentation of 132.There was some indication of restriction on the balloon waveform (b)(6) aspirated the inner lumen and flushed with the pump in standby for 15 seconds without issue.She stated the waveform and numbers were unchanged after the flush.Esp team member had asked her plug back in the fiber optic cable.Esp team member reviewed a screenshot that showed an arterial waveform with artifact an arterial pressure of 107/20 a mean of 110 and augmentation of 273.Esp team member agreed with (b)(6) that the fiber optic numbers were inaccurate.Esp team member recommended to her to use the transduced arterial pressure maintain inner lumen patency with flushes, alleviate the restriction if possible and to get a chest xray to confirm the radiopaque marker tip placement between the 2nd and 3rd intercostal space.(b)(6) explained she was a new graduate perfusionist and wanted to make sure she was providing appropriate care.She asked about the difference between bedside monitor pressures and pump pressures.Esp team member gave her a counterpulsation review and explained in depth the difference in pump and monitor pressures.Esp team member explained to (b)(6) and the bedside nurse the importance of inner lumen maintenance and cause of catheter restriction on the balloon waveform.The bedside nurse asked if the issues with the fiber optic could be because the balloon had been in 10 days.Esp team member explained there were several possible causes.Esp team member reviewed my recommendations from above with both of them.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• 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: 24066330
• Report Number: 2248146-2026-0000290
• Device Sequence Number: 21403243
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000428137(17)271031(11)241031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000428137
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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: PUMP.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 58 KG