BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1943987 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00875
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 1, 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) F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB A MALE MYOCARDIAL INFARCTION PT WAS HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED. THE LEFT FEMORAL ARTERY WAS ASSESSED AND A SUPER ARROW-FLEX (SAF) SHEATH INSERTED WITHOUT DIFFICULTY. THE MD VACUUMED THE IAB CATHETER TWICE INSIDE THE TRAY WITH THE ONE-WAY VALVE TO WRAP THE BALLOON TIGHTLY. THE CATHETER WAS REMOVED FROM THE TRAY HORIZONTALLY ACCORDING TO THE INSTRUCTIONS FOR USE. THE CATHETER PASSED THROUGH THE SAF SHEATH AND THEN IT LOOSENED, MAKING THE CATHETER UNABLE TO ADVANCE. THE MD REMOVED THE IAB AND SHEATH TOGETHER AND OPENED A NEW KIT. HE USED A NEW SAF SHEATH AND IAB VIA THE SAME INSERTION SITE. THERE WAS NO EXCESSIVE BLEEDING NOTED, WITH A DELAY OF ABOUT 10 MINUTES. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. THE PT OUTCOME IS 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. MF0021654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK