BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23219257 · Received October 6, 2025

    Report

    Report Number
    2248146-2025-0000581
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 11, 2025
    Report Date
    November 15, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K133074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION E1(INITIAL REPORTER): (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9(DEVICE AVAILABLE FOR EVAL), G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. ADDITIONAL REPORTER INFORMATION: (B)(6) CICU RN. CORRECTED FIELD: B5, D7A(SINGLE-USE DEVICE). NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. A 63-YEAR-OLD MALE PATIENT WAS UNDERGOING TREATMENT WITH A SENSATION PLUS BALLOON CATHETER WHEN A CICU RN, (B)(6), CONTACTED THE CLINICAL EMERGENCY SUPPORT LINE. ALTHOUGH ALL WAVEFORMS AND BLOOD PRESSURE INDICES WERE APPROPRIATE AND THE PUMP WAS USING THE FEMORAL ARTERY (FO) AS THE ARTERIAL PRESSURE SOURCE, THE INNER LUMEN OF THE CATHETER COULD NOT BE FLUSHED DESPITE MULTIPLE ATTEMPTS. TO MITIGATE THE RISK OF THROMBUS, THE INNER LUMEN WAS CAPPED AND LABELED ¿DO NOT USE.¿ THE CATHETER REMAINED IN USE WITH THE FO WAVEFORM, AND THE PHYSICIAN WAS NOTIFIED. NO PATIENT HARM OR INJURY OCCURRED. PRODUCT SURVEILLANCE WAS INITIATED, AND ARRANGEMENTS WERE MADE FOR THE CATHETER¿S RETURN. THE SUPPORT TEAM WAS NOTIFIED, AND THE NURSE WAS PROVIDED WITH DIRECT CONTACT INFORMATION FOR FURTHER ASSISTANCE. BASED ON THE DESCRIPTION, THERE SEEMS TO BE A POTENTIAL OF THROMBUS FORMATION OR INTERNAL OBSTRUCTION WITHIN THE INNER LUMEN OF THE BALLOON CATHETER, LEADING TO THE INABILITY TO FLUSH THE LUMEN DURING USE. IT IS IMPOSSIBLE TO DEFINE THE ROOT CAUSE OF THE REPORTED FAILURE. A BIOHAZARD WAS SENT TO THE CUSTOMER AND AN INVESTIGATION OF THE DEVICE WILL TAKE PLACE ONCE IT IS RECEIVED. THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. EACH IAB MANUFACTURED IS 100% INSPECTED AND THE CONTROLS PUT IN PLACE DURING THE MANUFACTURING OF THE IAB WOULD CATCH A DEFECT AND NOT ALLOW NON-CONFORMING DEVICE TO BE RELEASED. THE TREND REVIEW DID NOT IDENTIFY AN ADVERSE TREND (INCREASE IN NUMBER OF COMPLAINTS OVER PAST THREE (3) MONTHS). BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED. COMPLAINT ID# (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H6 (HEALTH EFFECT ¿ CLINICAL CODE), H11 CORRECTED FIELD - D10.

    Description of Event or Problem · 0

    THIS CALL WAS TAKEN FROM THE CLINICAL EMERGENCY SUPPORT LINE. IT WAS REPORTED BY CUSTOMER THAT DURING USE THE SENSATION PLUS 50CC (IAB) HAD ASPIRATE INNER LUMEN ISSUE. (B)(6) RN, CALLED REQUESTING ASSISTANCE FOR SENSATION PLUS BALLOON CATHETER DURING USE. SHE REPORTED THAT ALL WAVEFORMS AND BLOOD PRESSURE INDICES WERE APPROPRIATE, AND THAT THE PUMP WAS CURRENTLY USING THE FO AS THE AP SOURCE. RILEY STATED ¿THE INNER LUMEN WILL NOT FLUSH AT ALL. I HAVE TRIED MULTIPLE TIMES.¿ NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE INTRA-AORTIC BALLOON (IAB) WOULD NOT FLUSH INNER LUMEN. NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440219 SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0576-01 3000450011

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male