BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30 CC

    MDR report key: 3032945 · Received April 1, 2013

    Report

    Report Number
    1219856-2013-00080
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE PATIENT WHILE IN THE CATH LAB DURING INSERTION. THE MD ATTEMPTED TO INSERT THE PREPPED PER INSTRUCTION INTRA-AORTIC BALLOON (IAB) THROUGH THE TEFLON SHEATH VIA LEFT FEMORAL ARTERY AND THE IAB COULD NOT ADVANCE. AS A RESULT, THE IAB WAS REMOVED. THERE WAS NOT ANOTHER IAB INSERTED BECAUSE THE USER NEEDED A 30 CC IAB, BUT THEY WERE OUT OF STOCK. MEDICAL INTERVENTION WAS REQUIRED AS THE USER INJECTED MEDICAL SOLUTION FOR TREATMENT INSTEAD, WHICH HELPED WITH THE RECOVERY OF THE PATIENT'S CONDITION. THEY WERE UNABLE TO FINISH THE IAB THERAPY AS PLANNED. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS GOOD. THE SAMPLE IS NOT RETURNING DUE TO A KNOWN BLOOD PATHOGEN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 STATED THE USER USED A VASOPRESSOR; UNABLE TO GET INFORMATION ABOUT THE EXACT MEDICAL SOLUTION USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132552 IAB: 7.5 FR - 30 CC INTRA-AORTIC BALLON PRODUCTS DSP ARROW INTL., INC. KF1050217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN