BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7.5 FR - 40 CC

    MDR report key: 2150553 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00212
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE A MALE PT WAS IN THE CATH LAB. A SHEATHLESS (B)(4) WAS INSERTED BY THE MD VIA THE FEMORAL ARTERY WITHOUT PROBLEMS. AFTER INSERTION, BLEEDING WAS OBSERVED AT THE INSERTION SITE. AS A RESULT, THE MD REMOVED THE INTRA-AORTIC BALLOON (IAB). THE MD THEN INSERTED THE TEFLON SHEATH AND TRIED TO ADVANCE THE SAME IAB (WHICH WAS ALREADY USED) THROUGH THE SHEATH. THE IAB WAS UNABLE TO ADVANCE AND THEREFORE REMOVED. THE MD PROCEEDED WITH A NEW (B)(4) BECAUSE THERE WAS NOT ANOTHER 40CC AVAILABLE. THE IAB WAS INSERTED THROUGH THE SAME SHEATH WITH SUCCESS. THE DELAY OR INTERRUPTION OF THERAPY DID NOT CAUSE HARM TO THE PT. THERE WAS NO REPORT OF PT DEATH OR INJURY. THE PT OUTCOME IS THE PT IS ALIVE WITH NO COMPLICATIONS. THE SALES REP EXPLAINED TO THE CUSTOMER NOT TO INSERT A USED IAB AGAIN AND ALSO TO KEEP THE COMPLAINT DEVICE NEXT TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK