BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB:8 FR - 40 CC

    MDR report key: 1832053 · Received September 3, 2010

    Report

    Report Number
    1219856-2010-00593
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ARROW INTERNATIONAL 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 INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD PUNCTURED A PT'S LEFT FEMORAL ARTERY AND INSERTED A SUPER ARROW-FLEX (SAF) SHEATH WITH DILATOR. HE THEN ATTACHED A BLUE ONE-WAY VALVE AND VACUUMED BALLOON CATHETER TWICE INSIDE OF THE TRAY TO WRAP THE BALLOON TIGHTLY. GRASPING THE CATHETER CLOSELY, HE REMOVED IT FROM THE TRAY HORIZONTALLY PER THE INSTRUCTIONS FOR USE. HOWEVER, DURING THE INTRA-AORTIC BALLOON (IAB) INSERTION THROUGH THE SAF SHEATH, THE BALLOON STOPPED ADVANCING AND STUCK IN THE SAF SHEATH. THE MD TRIED TO ADVANCE THE BALLOON CATHETER, BUT HE COULD NOT PASS IT THOUGH THE SAF SHEATH DUE TO CRITICAL RESISTANCE. AS A RESULT, THE MD HAD TO REMOVE THE SAF SHEATH AND BALLOON CATHETER TOGETHER. A NEW IAB-05840-U WAS OPENED AND IN THE SAME INSERTION SITE (LEFT FEMORAL ARTERY), THE MD INSERTED THE NEW SAF SHEATH AND CATHETER AND FINISHED THE CATHETERIZATION. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY IN THERAPY OF 10 MINS. THERE WAS NO EXCESSIVE BLEEDING DURING THE PROCEDURES. THE PT OUTCOME IS LISTED AS "THE PT DOES NOT HAVE ANY COMPLICATIONS AND 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 INTERNATIONAL INC. MF9100025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK