BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES

    MDR report key: 19650863 · Received July 1, 2024

    Report

    Report Number
    2248146-2024-00400
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 11, 2024
    Report Date
    November 20, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108063
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTER: (B)(6), ICU RN, (B)(6) ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: HMH PRESSURE TUBING TRANSPAC 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

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5). COMPLAINT RECORD ID # (B)(4).

    Additional Manufacturer Narrative · 0

    THE IAB WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE RETURNED SHEATH WAS OVER THE CATHETER AND PARTIALLY COVERING THE REAR PORTION OF THE BALLOON. THE RETURNED SHEATH WAS NOT A MAQUET PRODUCT. THE EXTENDER TUBING WAS ALSO RETURNED. THE SHEATH WAS FOUND SEVERELY KINKED IN TWO PLACES NEAR THE PROXIMAL END. UNDERNEATH THE SHEATH THE CATHETER TUBING AND INNER LUMEN WAS FOUND KINKED APPROXIMATELY 29.2CM AND 32.3CM FROM IAB TIP. ADDITIONALLY THE CATHETER TUBING AND INNER LUMEN WAS FOUND KINKED NEAR THE Y-FITTING APPROXIMATELY 75.9CM FROM IAB TIP. A SENSOR OUTPUT TEST WAS PERFORMED AND THE SENSOR WAS FOUND TO BE WITHIN SPECIFICATION. THE TECHNICIAN ATTEMPTED TO INSERT A 0.025¿ LABORATORY GUIDE WIRE THROUGH THE INNER LUMEN OF THE RETURNED IAB AND FOUND THAT THE INNER LUMEN KINKED AND OCCLUDED. THE TECHNICIAN WAS UNABLE TO CLEAR THE OCCLUSION, HOWEVER EVIDENCE OF DRIED BLOOD WAS OBSERVED AT THE TIP OF THE GUIDE WIRE. THE CONDITION OF THE IAB AS RECEIVED INDICATED KINKS ON THE CATHETER TUBING AND INNER LUMEN AND AN OCCLUSION IN THE INNER LUMEN. THE EVALUATION CONFIRMS THE REPORTED CLOTTED LUMEN AND DIFFICULTY TO FLUSH AND ASPIRATE THE INNER LUMEN. WE ARE UNABLE TO DETERMINE HOW THIS MAY HAVE OCCURRED. THE REPORTED SENSOR FAILURE CANNOT BE CONFIRMED BY THE EVALUATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER APPROXIMATELY 11 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, A FIBER OPTIC SENSOR OCCURRED. THE CUSTOMER WAS WALKED THROUGH TROUBLESHOOTING WITHOUT SUCCESS. THE GETINGE REPRESENTATIVE EXPLAINED THAT THEY NEEDED TO SWITCH TO THE USE OF THE TRANSDUCER AS ANOTHER PRESSURE SOURCE AND THAT THE PRESSURE INPUT CABLE NEEDED TO BE CONNECTED THE TRANSDUCER. THE CUSTOMER STATED THERE WAS REGULAR IV TUBING CONNECTED TO THE INNER LUMEN NOT A PRESSURE BAG AND TRANSDUCER SET. IT WAS EXPLAINED THAT THEY NEEDED TO SET UP A PRESSURE BAG AND TRANSDUCER SET LIKE AN ARTERIAL LINE SET UP THEN CALL BACK. THEY CALLED BACK APPROXIMATELY 5 MINUTES LATER AND STATED THEY HAD SET THE PRESSURE BAG UP, BUT THE LINE WOULD NOT FLUSH. THEY WERE UNABLE TO ASPIRATE FROM THE INNER LUMEN. IT WAS EXPLAINED THAT THIS MEANT THAT THE INNER LUMEN WAS CLOTTED, AND THEY WOULD NEED TO CAP IT AND LABEL ¿DO NOT USE.¿ IT WAS REVIEWED THAT THEY WOULD NEEDED AN ALTERNATE PRESSURE SOURCE TO SAFELY AND APPROPRIATELY TIME THE PUMP. IT WAS EXPLAINED THAT WITHOUT THE FIBER OPTIC AND THE INNER LUMEN AS OPTIONS, THEY WOULD NEED TO CALL THE PHYSICIAN AND REQUEST AN ALTERNATE LINE (PREFERABLY RADIAL) OR SUGGEST REPLACEMENT OF THE IAB. IT WAS LATER REPORTED THAT THERAPY WAS DISCONTINUED AND THE IAB WAS REMOVED AFTER 12 HOURS OF USE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996597 SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0568-01 3000366457 10607567108063

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female CS300 TRANSPAC TRANSDUCER