BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1757166 · Received June 18, 2010

    Report

    Report Number
    1219856-2010-00416
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 16, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WHILE IN THE CARDIAC CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE MD INSERTED THE SHEATH INTO THE PATIENT'S RIGHT FEMORAL ARTERY. AFTER THE MD INSERTED THE IAB THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH THE IAB FAILED TO UNWRAP COMPLETELY. THE PUMP ALARMED "KINKED CATHETER ARM." THE IAB UNWRAPPED ABOUT 1/2; HOWEVER, IT WOULD NOT UNWRAP IN THE DISTAL PORTION OF THE IAB. THEY CONTINUED TO PUMP, BUT THE IAB WOULD NOT UNWRAP COMPLETELY. AS A RESULT, THE IAB AND THE SAF SHEATH WERE REMOVED. ANOTHER SAF SHEATH AND IAB WERE INSERTED OVER THE EXISTING SPRING WIRE GUIDE (SWG) WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO REPORTED DELAY IN THERAPY. THE PATIENT OUTCOME IS LISTED AS "UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC MF0011098

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR