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	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) rn ccu called for assistance with a fiber optic sensor failure alarm on a cardiosave during use.(b)(6) denied any kink or fold in the fo cable and stated that she had already unplugged and re plugged the fo sensor cable once before.Esp personnel asked her to repeat the step verifying that it was arrow to arrow and seated appropriately.Esp personnel then reviewed the steps to transition from fo to transducer as the pressure source and requested she coil tape and label the fo cable as fiber optic sensor failure do not use.Complaint information obtained.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).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 are as follows a sensor failure can result from the following, optical sensor kink, break in sensor, connector issue.

• 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: 24902767
• Report Number: 2248146-2026-0000910
• Device Sequence Number: 10011804
• 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: NY
• 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,Followup
• Report Date (Section B): 05/10/2026

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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/10/2026
• 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 Sex: Unknown