BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 3063308 · Received April 11, 2013

    Report

    Report Number
    1219856-2013-00094
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EVENT INVOLVED A MALE PATIENT, AGE STATED AS (B)(6). THE EVENT OCCURRED IN THE CATH LAB. INDICATION FOR USE: SUPPORT DURING CATH LAB PROCEDURE. FOLLOWING THE INTRA-AORTIC BALLOON (IAB) INSERTION THROUGH THE WHITE SHEATH WITH SIDEARM AND AT THE TIME OF INITIATION OF INTRA-AORTIC BALLOON PUMP (IABP) THERAPY, IT WAS NOTED THAT BLOOD WAS IN THE TYGON GAS TUBING NEAR THE TUBING CONNECTION. IT WAS SUSPECTED THAT THERE WAS A POSSIBLE MEMBRANE LEAK/TEAR OR CENTRAL LUMEN BREAK TO ALLOW BLOOD INTO THE GAS LUMEN. AS A RESULT, THE IAB AND SHEATH WERE REMOVED AS ONE UNIT. THE MD REPLACED THE IAB WITH ANOTHER 400CC FIBEROPTIX SENSOR (FOS) IAB AT THE SAME FEMORAL SITE USING A COMPLETELY NEW IAB KIT AND SHEATH. THE NEW REPLACEMENT IAB CATHETER WAS INSERTED SUCCESSFULLY OVER AN EXCHANGE SPRING WIRE GUIDE. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. ACCORDING TO THE REPORT THERE WAS NO DELAY OR INTERRUPTION OF IABP THERAPY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT OUTCOME IS LISTED AS "PROCEDURE COMPLETED NORMALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154668 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP