BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 9 FR - 50 CC

    MDR report key: 2243863 · Received August 24, 2011

    Report

    Report Number
    1219856-2011-00302
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K010330
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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 REPORTED THAT THE RN FROM THE CATH LAB PHONED THE CLINICAL SUPPORT SPECIALIST (CSS) POST INSERTION TO REPORT ISSUES INSERTING A 50CC INTRA-AORTIC BALLOON (IAB). THE RN STATED THAT THE IAB BECAME STUCK IN THE SHEATH APPROXIMATELY 1-2 INCHES INTO THE SHEATH (SHEATH FROM IAB KIT). ACCORDING TO THE RN, THEY WERE UNABLE TO ADVANCE THE CATHETER THROUGH THE SHEATH SO THEY LEFT THE SHEATH IN PLACE AND INSERTED A 40CC IAB. THE SECOND IAB INSERTED WITHOUT ISSUE. THE PT IS NOW STABLE ON THE PUMP WITH MINIMAL DELAY IN THERAPY. THE CSS DISCUSSED IAB PREP TECHNIQUES WITH THE RN. THE RN TOLD THE CSS THAT "SHE WAS NOT THERE AT THE INSERTION, HOWEVER, THE DOCTOR INSERTING WAS VERY EXPERIENCED." THE RN REPEATED THE PROPER IAB PREP STEPS TO THE CSS. THE RN TOLD THE CSS THAT THE IAB DID NOT APPEAR TO BE UNWRAPPING UNTIL AFTER IT BECAME STUCK. THE RN HAS THE IAB FOR RETURN. THE 9FR SHEATH WILL NOT BE RETURNED AS THEY USED IT FOR THE PLACEMENT OF THE SECOND IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 9 FR - 50 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. KF1060449

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK