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	Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
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 40cc had fiber optic sensor failure and difficult or unable to monitor arterial pressure waveform.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
(b)(6).A fiber optic sensor failure occurred in an intra aortic balloon catheter inserted via the axillary approach, resulting in loss of the fiber optic pressure signal.The nurse contacted for assistance due to poor arterial waveform quality and an unable to update timing alarm on the iabp.The console defaulted to using the transducer as the arterial waveform source, and a screenshot showed a significantly dampened waveform.After ct surgery aspirated and flushed the inner lumen, all waveforms and blood pressure indices returned to appropriate ranges.She was informed that a biohazard kit would be sent to collect the catheter once removed due to the fiber optic sensor failure.Product surveillance was completed, no prior complaint was found for this issue, and no patient harm or injury was reported.

• 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: 25110516
• Report Number: 2248146-2026-0000992
• Device Sequence Number: 13084528
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000503087(17)280924(11)250924
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 3000503087
• 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: 04/14/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 79 KG