BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1842070 · Received August 27, 2010

    Report

    Report Number
    1219856-2010-00565
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, A MALE PATIENT WAS PREPPED FOR THE INSERTION OF A INTRA-AORTIC BALLOON (IAB). THE PHYSICIAN ACCESSED THE LEFT FEMORAL ARTERY AND INSERTED A SUPER ARROW-FLEX (SAF) SHEATH WITH DILATOR. HE ATTACHED A BLUE ONE-WAY VALVE, VACUUMED THE BALLOON CATHETER TWICE INSIDE OF TRAY TO WRAP THE BALLOON TIGHTLY. HE GRASPED THE CATHETER AND REMOVED IT FROM THE TRAY HORIZONTALLY FOLLOWING THE INSTRUCTIONS FOR USE. DURING INSERTION, THE IAB UNWRAPPED RIGHT AWAY. THE PHYSICIAN TRIED TO ADVANCE THE BALLOON CATHETER, BUT IT WOULD NOT PASS THROUGH THE SAF SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER. A NEW KIT OF THE SAME SIZE WAS OPENED AND A NEW SHEATH AND BALLOON WERE USED TO SUCCESSFULLY PLACE THE IAB VIA THE SAME INSERTION SITE. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. THE PATIENT REQUIRED NO MEDICAL/SURGICAL INTERVENTION AND DELAY IN TREATMENT WAS 10 MINUTES. THE PATIENT DID NOT HAVE ANY COMPLICATIONS OR EXCESSIVE BLEEDING DURING THE PROCEDURE AND WAS REPORTED AS "FINE".

    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. MF9067275

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK