BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 3063346 · Received April 11, 2013

    Report

    Report Number
    1219856-2013-00090
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE PATIENT WHILE IN THE CATH LAB. THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE TEFLON SHEATH VIA RIGHT FEMORAL ARTERY WITH NO ISSUES. DURING PUMPING, POSSIBLE HELIUM LEAK ALARM WENT OFF. AS A RESULT, THE IAB AND TEFLON SHEATH WERE REMOVED TOGETHER AS ONE UNIT. A NEW IAB WAS INSERTED VIA THE SAME INSERTION SITE (RIGHT FEMORAL ARTERY) SUCCESSFULLY. THE PATIENT HAD MILD CALCIFICATION IN THE VESSEL. THERE WERE PUMP STRIPS GENERATED FOR REVIEW. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY JUST LONG ENOUGH TO REPLACE THE IAB WITH NO HARM TO THE PATIENT. THE PATIENT OUTCOME IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155544 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM DSP ARROW INTL., INC. KF 1070875

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INTRA-AORTIC BALLOON PUMP