BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR-40 CC FOS

    MDR report key: 1673188 · Received April 30, 2010

    Report

    Report Number
    1219856-2010-00291
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 10, 2010
    Report Date
    April 29, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR # 1219856-2010-00290 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE PHYSICIAN USED THE SUPER ARROW-FLEX (SAF) SHEATH TO INSERT THE BALLOON IN THE LEFT FEMORAL ARTERY. DURING THE INSERTION, THE BALLOON WAS BLOCKED ON THE SHEATH. THE PHYSICIAN PUSHED THE BALLOON INTO THE SHEATH AND HE SUCCEEDED TO PLACE THE BALLOON IN THE AORTIC ARCH. WHEN HE CONNECTED TO THE INTRA-AORTIC BALLOON PUMP, THE BALLOON DID NOT INFLATE CORRECTLY; ONLY A SMALL PART INFLATED AND AN ALARM MESSAGE APPEARED "KINK PROBLEM." THE PHYSICIAN REMOVED THE INTRA-AORTIC BALLOON (IAB) AND THE SHEATH AS ONE UNIT. ADDITIONAL INFO RECEIVED BY THE QUALITY ASSISTANT FROM THE PHYSICIAN STATED THE PT DIED 48 HOURS LATER, DUE TO CARDIOGENIC SHOCK AND SEVERE TROUBLE OF VENTRICULAR RHYTHM. NEVERTHELESS, THE MD STATED THE DEATH COULD NOT BE DIRECTLY IMPUTED TO THE ABSENCE OF COUNTERPULSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR-40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF9110300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death INTRA-AORTIC BALLOON PUMP