BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 3162483 · Received June 6, 2013

    Report

    Report Number
    1219856-2013-00127
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS BEING REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB DURING REMOVAL. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE TEFLON SHEATH VIA RIGHT FEMORAL ARTERY WITH NO ISSUES. THERE WAS NO CALCIFICATION OR A TORTUOUS VESSEL AND THERE WAS NO RESISTANCE FELT DURING THE INSERTION OF THE IAB. APPROXIMATELY ONE HOUR LATER THE USER ATTEMPTED TO REMOVE THE IAB. THE USER FELT RESISTANCE AND WAS UNABLE TO REMOVE THE IAB. AS A RESULT, AFTER TRYING MULTIPLE TIMES THE USER SUCCESSFULLY REMOVED THE IAB. THERE WAS NOT ANOTHER IAB INSERTED. AFTER THE REMOVAL, BLOOD WAS OBSERVED INSIDE THE IAB. THERE WERE NO ALARMS THAT WENT OFF. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY SINCE THIS OCCURRED DURING REMOVAL. THE PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THE IAB WAS USED BECAUSE THE PATIENT CONDITION GOT WORSE WHILE HAVING THE PCI (PERCUTANEOUS CORONARY INTERVENTION) TREATMENT. AFTER RECOVERY, THERE WAS NO MORE NEED FOR PCI TREATMENT, SO THE USER STOPPED THE PCI TREATMENT AND REMOVED THE IAB AS WELL. THE USER STATED THAT THE IAB HAD NOT BEEN DAMAGED DURING THE REMOVAL EVEN WITH THE MANY ATTEMPTED TIMES. THEY DID NOT INSERT ANOTHER IAB BECAUSE NO FURTHER TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251791 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF2083890

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON PUMP