MAUDE Adverse Event Report: DATASCOPE CORP.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-05
Medical Device Problem Codes	Restricted Flow rate (1248); Device Sensing Problem (2917); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6) event site address: (b)(6) brand name: sensation plus 8fr 50cc iab with accessories (w/pressure tubes, no stylet, w/o statlock) (china) 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
The complaint was received through a direct call from the customer (registered nurse) to the emergency support program.It was reported that while using sensation plus 8fr 50cc intra-aortic balloon (iab), the device experienced a fo sensor failure and iab catheter restriction.No harm or injury to the patient was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field - h6 (medical device problem code, type of investigation, investigation findings, component codes, investigation conclusions).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6(type of investigation, investigation findings, component code, conclusion), h11.Corrected fields: d4(udi).A fiber optic sensor failure in an intra aortic balloon occurs when the pressure sensor fails to transmit accurate aortic pressure waveforms needed for proper balloon timing.A nurse reported a fiber optic sensor failure and catheter restriction but stated the patient had not moved or bent the leg.All attempts to restore the fiber optic arterial pressure waveform were unsuccessful.A rolled towel was placed under the patient to straighten a possible kink near the inguinal crease which allowed therapy to restart using the iab fill and start keys.The fluid filled inner lumen was already transduced but a pressure cable was not available at the time to connect it to the pump.No patient harm was reported and limited surveillance information was obtained before the call ended with no further follow up.
Event or Problem Description
N/a.

• 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: 24636734
• Report Number: 2248146-2026-0000787
• Device Sequence Number: 9192557
• Product Code: DSP
• UDI-Device Identifier: 10607567109381
• UDI-Public: (01)10607567109381(10)3000472788(17)280205(11)250205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 04/09/2026

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: 0684-00-0576-05
• Device Catalogue Number: 0684-00-0576-05
• Device Lot Number: 3000472788
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/09/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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 Sex: Unknown