BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)

    MDR report key: 24160836 · Received January 23, 2026

    Report

    Report Number
    2248146-2026-0000532
    Event Type
    Death
    Date Received
    January 23, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 19, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K133074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A SENSOR FAILURE CAN OCCUR DUE TO ONE OR MORE OF THE FOLLOWING PROBABLE CAUSES: CAUSES OF A SENSOR FAILURE: A SENSOR FAILURE CAN RESULT FROM THE FOLLOWING: OPTICAL SENSOR KINK. BREAK IN SENSOR. CONNECTOR ISSUE. THE ISSUE WAS MANAGED BY EXCHANGING THE PUMP AND BALLOON CATHETER, AFTER WHICH THE FIBER OPTIC SENSOR ALARM RESOLVED AND THE PATIENT SHOWED TEMPORARY STABILIZATION. HOWEVER, THE PATIENT EXPERIENCED RECURRENT DETERIORATION WITH A SECOND CODE BLUE EVENT AND ULTIMATELY EXPIRED DUE TO SEVERE UNDERLYING CARDIAC CONDITIONS. BASED ON AVAILABLE INFORMATION, THE ALARM WAS NOT INDICATIVE OF A PUMP MALFUNCTION BUT WAS MORE CONSISTENT WITH CATHETER- OR PATIENT-RELATED FACTORS. BIOMED EVALUATION AND FURTHER TECHNICAL SUPPORT WERE RECOMMENDED AS PRECAUTIONARY MEASURES.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM THAT A PATIENT DIED ON CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THE DEVICE HAD UNABLE TO CALIBRATE FIBER-OPTIC SENSOR ALARM FOLLOWED BY AN ACUTE DROP IN AUGMENTATION. THE CUSTOMER WAS UNSURE IF THE AUGMENTATION DROP CORRELATED WITH BLOOD PRESSURE. THEY EXCHANGED THE PUMP TO RESOLVE ALARM AND FLUSHED CATHETER BUT WAS SLUGGISH. CALLED CLINICAL SUPPORT LINE AT 1:54 AM EST BUT ESP TEAM MEMBER COULD NOT MAKE CONTACT WITH (B)(6) (THE BEDSIDE NURSE.) BETWEEN THE CALL BACK TIME, PATIENT BECAME UNRESPONSIVE AND CODE BLUE CALLED. PATIENT WAS GIVEN ACLS FOR AN UNKNOWN PERIOD OF TIME AND OBTAINED ROSC. CUSTOMER EXCHANGED BALLOON CATHETER, KEEPING PUMP 2 IN USE. THE ORIGINAL CATHETER WAS ACCIDENTALLY DISPOSED OF. MOMENTARY STABILIZATION OF PATIENT AFTER ACLS AND UNABLE TO CALIBRATE FIBER-OPTIC SENSOR ALARM RESOLVED. HOWEVER, AUGMENTATION DROPPED AGAIN, PATIENT BECAME UNRESPONSIVE AND CODE BLUE WAS CALLED FOR A SECOND TIME. FAMILY DECIDED TO NOT ESCALATE CARE AND PATIENT PASSED AWAY AT 3:44 AM EST. THE PATIENT HAD BEEN ADMITTED TO THE UNIT AFTER STENTING, DIAGNOSTICS, AND BALLOON PUMP PLACEMENT IN THE CCL. THE PATIENT HAD SEVERE AORTIC STENOSIS, MITRAL REGURG, TRICUSPID REGURG AND COUNTERPULSATION THERAPY WAS STARTED AS A BRIDGE TO TAVR DURING THE WORKUP PROCESS. CUSTOMER WAS UNSURE OF THE PATIENT¿S EF OR CI BUT AGREED THE PATIENT HAD MULTIPLE CARDIAC DIAGNOSES CONTRIBUTING TO POOR FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270047 SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0576-01 3000436705 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death CARDIOSAVE