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

Model Number	0684-00-0608
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	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use, intra aortic balloon (iab) sensor did not display blood pressure.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields b4, d9, g3, g6, h2, h3, h6 type of investigation findings component code investigation conclusions, h11.Corrected field is e3, h6 medical device problem product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, a fiber optic sensor failure can occur due to one or more of the following probable causes iab sensor failure a fiber optic sensor failure in an intra-aortic balloon refers to the malfunction or loss of signal from the fiber optic pressure sensor within the intra-aortic balloon catheter.This sensor is responsible for accurately detecting and transmitting real-time aortic pressure waveforms to the iabp console, which are critical for timing the inflation and deflation of the balloon during cardiac cycles.Causes of a sensor failure: a sensor failure can result from the following: 1 optical sensor kink.2 break in sensor.3 connector issue.Difficult unable to monitor arterial pressure a condition in which the intra aortic balloon pump iabp cannot obtain a reliable arterial pressure waveform due to issues such as sensor failure fiber optic iab calibration failure or disconnection and 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 loose connections or patient related factors like low pulse pressure or arrhythmias in these situations the arterial signal becomes inaccurate or unusable for safe iabp operation product was not returned so an exact cause of the issue could not be identified however based on our investigation a difficult or unable to monitor pressure waveform can occur due to one or more of the following probable causes causes of arterial pressure.1 blood clot thrombus formation within the inner lumen, 2 a break in the inner lumen, 3 a kink in the inner lumen, 4 fiber optic iab calibration failure or disconnection, 5 fiber optic cable break, 6 fiber optic cable kink, 7 transducer not zeroed or vented properly, 8 over damped or flat arterial pressure waveform due to bubbles or excessive tubing compliance, 9 loose or incorrect pressure cable connections, 10 patient condition low pulse pressure arrhythmias, 11 off label use.

• Brand Name: TRANS-RAY PLUS 7.5FR 40CC IAB WITH 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: 24482384
• Report Number: 2248146-2026-0000738
• Device Sequence Number: 21492301
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)280402(10)3000464531(11)250402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000464531
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 68 KG