BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 3063703 · Received April 12, 2013

    Report

    Report Number
    1219856-2013-00097
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 11, 2013
    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). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2013-00096 FOR THE FIRST EVENT WITH THE SAME PT. IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE OP DURING USE. THE SECOND INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE SAME INSERTION SITE (LEFT FEMORAL) WITH NO ISSUES. AFTER THE IAB WAS PLACED THEY WERE UNABLE TO REMOVE THE SPRING WIRE GUIDE (SWG). AS A RESULT, THE SWG AND IAB WERE REMOVED SUCCESSFULLY. A THIRD IAB WAS INSERTED VIA THE SAME INSERTION SITE (LEFT FEMORAL) SUCCESSFULLY. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL / SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN UNK TIME OF DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT. THE PT OUTCOME IS OKAY. ADDITIONAL INFO RECEIVED ON (B)(6) 2013 STATED THAT OP STANDS FOR OPERATING THEATER. THERE WERE NO ISSUES DURING THE INSERTION. THE PT DID NOT HAVE A TORTUOUS VESSEL. THE THIRD IAB INSERTION SITE WAS THE SAME (LEFT FEMORAL), BUT IT IS UNK IF IT WAS SHEATHLESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158208 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF2083935

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK