BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1772600 · Received July 23, 2010

    Report

    Report Number
    1219856-2010-00509
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2010-00508 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED, VASCULAR ACCESS ACHIEVED, SUPER ARROW-FLEX (SAF) SHEATH INSERTED INTO THE PT'S LEFT FEMORAL ARTERY. AS THE MD WAS INSERTING THE IAB INTO THE SAF SHEATH, THE IAB BECAME STUCK IN THE SAF SHEATH. THE IAB GOT STUCK IN THE MIDDLE OF THE SHEATH INTRODUCER. IT WAS IMPOSSIBLE TO PULL BACK THE CATHETER, SO A COMPLETE REMOVAL OF SHEATH, SPRING WIRE GUIDE (SWG) AND IAB WAS NECESSARY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO REPORTED PT COMPLICATIONS. THE DELAY IN THERAPY IS LISTED AS 15 MINUTES TOTAL. THE PT OUTCOME IS LISTED AS "FINE." A THIRD IAB (IAB-05840-U) WAS SUCCESSFULLY INSERTED, HOWEVER, THERE IS NO INFORMATION AVAILABLE ABOUT THE INSERTION SITE OF THE THIRD IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF9088685

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other