MAUDE Adverse Event Report: Datascope Corp. Sensation Plus 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0576-01U
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, a ccu rn reported a fiber-optic sensor failure on a cardiosave intra-aortic balloon pump (iabp) during support with a sensation plus 8fr.50cc intra-aortic balloon (iab).No harm was reported.The customer attempted to disconnect and reconnect the fiber-optic (fo) cable and perform a flush without resolution, and subsequently transitioned to the transduced inner lumen as the arterial pressure source.An appropriate arterial pressure waveform and pressure indices were reported after transition to the transducer.Additional troubleshooting of the fo system was offered but declined.The customer was advised to coil the fo cable and label it "do not use." the customer confirmed that the pressure bag was maintained approximately three feet above the transducer on a standard iv pole.Information required for shipment of a biohazard return kit was obtained, and instructions for catheter return were provided.
Additional Manufacturer Narrative
E1 - event site name: (b)(6) upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Sensation Plus 8Fr. 50cc IAB with Accessories, US Only
• 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: 50943368
• Report Number: 2248146-2026-0001587
• Device Sequence Number: 10348603
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000518873
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• 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 IABP
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 189 LB