BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA AORTIC BALLOON

    MDR report key: 4987588 · Received August 5, 2015

    Report

    Report Number
    2248146-2015-00067
    Event Type
    Death
    Date Received
    August 5, 2015
    Report Date
    July 7, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AN TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4) .

    Description of Event or Problem · 1

    THIS COMPLAINT IS TO REPORT THE EVENT ON THE 2ND BALLOON AS DEATH. THE FIRST COMPLAINT WILL BE REPORTED VIA AN ALTERNATIVE SUMMARY REPORT. THE CVOR STAFF CALLED AT THE END OF A CAB CASE. THEY HAD INSERTED A 7 FR SENSATION AND GO THE "CHECK CATHETER" ALARM ON START UP. SINCE IT WOULDN'T PUMP THEY ALSO GOT A "UNABLE TO CALIBRATE" MESSAGE. THEY USED THE SHEATH IN THE KIT AND VERIFIED THAT THE IAB WAS IN FAR ENOUGH TO CLEAR THE SHEATH. THE COMPANY REPRESENTATIVE SUGGESTED THAT THE CATHETER WAS KINKED EITHER AT THE INSERTION SITE OR INTERNALLY. THE REP WALKED THEM THROUGH DOING A MANUAL INFLATION. THERE WAS NO EVIDENCE OF BLOOD IN THE CATHETER AFTER THE ASPIRATION BUT THEY WERE UNABLE TO INSERT GAS INTO THE CATHETER. IT WAS SUGGESTED BY THE REP THAT THIS CONFIRMED THE CATHETER WAS SIGNIFICANTLY KINKED. THEY REPLACED IT WITH A SECOND 7 FR SENSATION. THE REP ASKED THEM TO CONFIRM THAT THEY PLACED THE WIRE FULLY PRIOR TO ADVANCING THE BALLOON AND HAD NOT PRELOADED OR BACKLOADED WITH WIRE. THE REP ALSO ASKED THAT THEY USE 1 INCH INCREMENTS TO ADVANCE THE SECOND IAB. THEY SAID THAT THEY HAD DONE IT CORRECTLY AND DID NOT SEE A KINK IN THE REMOVED BALLOON. THE SECOND BALLOON WAS INSERTED AND THEY RECEIVED BOTH A "CHECK CATHETER" ALARM AFTER 2 INFLATIONS AND AN AUTOFILL FAILURE ALARM. THE NURSE SAID THAT WITH THIS BALLOON THEY ALSO DID NOT GET AN ARTERIAL WAVEFORM ON THE SCREEN. AT THIS POINT THE PERSON ON THE PHONE WAS INVOLVED IN OBTAINING ANOTHER CATHETER AND OTHER THAN CONFIRMING SIZING ISSUES FOR INSERTION OF A SENSATION PLUS. THE REP DID NOT SPEAK TO HER AGAIN. ANOTHER WOMAN WHOSE, SPOKE INTERMITTENTLY TO THE REP AFTER THAT BUT THEY HAD THE PHONE ON SPEAKER TO THE ROOM. THE REP REMINDED THEM ABOUT NEEDING TO DO A SHEATH EXCHANGE FOR USING THE SENSATION PLUS. THE INSERTION WENT WELL AND THE PUMP BEGAN PUMPING. THEY SAID THEY DIDN'T HAVE AN ARTERIAL TRACING WITH THE FIBEROPTIC PLUG INSERTED HOWEVER. SHE TRANSDUCED THE CENTRAL LUMEN AND OBTAINED AN ARTERIAL SIGNAL AFTER THE REP ADVISED HER TO PULL OUT THE FIBEROPTIC PLUG. A CHEST FILM WAS TAKEN AT THAT POINT. SHE WAS UNDER IMPRESSION THAT THE PUMP ONLY WORKED WHEN THERE WAS AN ARTERIAL WAVEFORM BUT THE REP EXPLAINED THAT IN ECG TRIGGER THOSE 2 THINGS WOULD NOT BE RELATED AND ASKED THAT ONCE ALL THE DRAMA WAS OVER WE COULD FURTHER TROUBLESHOOT GETTING THE PUMP TO USE THE FIBER OPTIC SIGNAL. THE PT WENT INTO FULL ARREST. THE REP ASKED FOR CLARIFICATION OF THE OUTCOME AND STATED THAT THEY WOULD LIKE THE SENSATION BALLOONS ASSESSED. THEY ASKED FOR CLARIFICATION OF THE OUTCOME AND STATED THAT THEY WOULD LIKE THE SENSATION BALLOONS ASSESSED. THEY ASKED FOR THE INFORMATION FOR COMPLAINT REPORTING AND THAT THEY WOULD SAVE THE BALLOONS. THE PHYSICIAN AND OR STAFF THAT THEY REPORTED A VERY TORTUOUS AORTA. THERE IS NO POST MORTEM. THEY WILL NOT BE RETURNING BALLOONS. THEY ARE NOT ASSERTING THAT THEY BALLOONS WERE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515498 INTRA AORTIC BALLOON SENSATION 7FR DSP MAQUET CARDIOVASCULAR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death