BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 3122197 · Received May 17, 2013

    Report

    Report Number
    1219856-2013-00115
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RN PHONED THE CLINICAL SUPPORT SPECIALIST (CSS) STATING THAT THE EVENT INVOLVED A (B)(6) FEMALE. ON (B)(6) 2013, THE PT WAS ADMITTED TO THE CARDIAC CARE UNIT (CCU) WITHOUT ISSUE. INDICATION FOR INTRA-AORTIC BALLOON (IAB) USE: STATUS POST (S/P) INFERIOR WALL MYOCARDIAL INFARCTION (MI), 4 STENTS PLACED TO RIGHT CORONARY ARTERY (RCA) (B)(6) 2013. AN IAB WAS INSERTED VIA THE PT'S RIGHT FEMORAL ARTERY. ON (B)(6) 2013, THE PUMP (S/N (B)(4)) ALARMED HE (HELIUM) LOSS AND THERE WAS A LARGE AMOUNT OF FROTHY, FRANK ARTERIAL BLOOD NOTED IN THE DRIVELINE. ACCORDING TO THE MD, THE IAB WAS "QUICKLY" REMOVED FROM THE RIGHT FEMORAL ARTERY BY THE MD (FELLOW) AND THE ATTENDING MD. NO REPORT OF BLOOD REACHING BACK TO THE PUMP. A SECOND IAB (S/N (B)(4)) WAS EMERGENTLY INSERTED VIA THE PT'S LEFT FEMORAL ARTERY. A SECOND PUMP WAS USED FOR THIS PT. THE RN NEEDED ASSISTANCE WITH THE ADJUSTMENT OF THE MEAN ARTERIAL PRESSURE (MAP) VALUE FOR THE SECOND IAB. THE CSS HELPED THE RN ADJUST THE MAP VALUE TO MATCH THE PRESSURE FROM A TRANSDUCED ARTERIAL LINE. POST RUPTURE THE PT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY AND WAS NOTED TO HAVE NEW ONSET R HEMIPLEGIA. NEURO WAS EMERGENTLY CONSULTED, BUT CAME DURING THE INSERTION OF THE SECOND IAB AND IS GOING TO COME BACK LATER IN THE MORNING FOR A FULL ASSESSMENT. NO CONCLUSIVE INFORMATION ON THE PRELIMINARY FINDINGS FROM NEURO. LEFT SIDE IS MOVING PURPOSEFULLY WHILE SEDATED AND INTUBATED. THE PT'S PUPIL'S BILAT EQUAL HOWEVER SLUGGISH TO RESPOND. THE PT IS NOW BEING SUPPORTED APPROPRIATELY ON SECOND IAB/P. THERE WAS NO REPORTED PT DEATH, HOWEVER THERE WAS A DELAY IN IABP THERAPY FOR AN UNKNOWN TIMEFRAME. THERE WERE REPORTED PT COMPLICATION NOTED AS POSSIBLE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219710 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention INTRA-AORTIC BALLOON PUMP