BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR-40 CC FOS

    MDR report key: 1943966 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00878
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 21, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A FEMALE PATIENT WAS IN THE CATH LAB HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED. THE FEMORAL ARTERY WAS ACCESSED AND THE IAB PREPPED. WHILE INSERTING IT THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH IT ADVANCED HALF WAY TO T12-L1 LEVEL WHEN THE PHYSICIAN MET RESISTANCE. THE CATH LAB EQUIPMENT MANAGER TOLD HIM TO REMOVE THE IAB. THE IAB WAS REMOVED EASILY THROUGH THE SHEATH, RE-PREPPED TWICE AND AGAIN ATTEMPTED TO BE REINSERTED THROUGH THE SAF SHEATH. IT AGAIN MET RESISTANCE AND THEY REMOVED THE IAB AND SHEATH FROM THE PATIENT. A NEW IAB CATHETER WAS OBTAINED WITH A BRAIDED SHEATH AND WAS EASY TO INSERT. THERE WAS A DELAY OF A FEW MINUTES NOTED IN THERAPY. NO PATIENT DEATH, INJURIES OR COMPLICATIONS ARE NOTED. THE PATIENT IS ALIVE AND PROGRESSING, WITH THE IAB TO BE REMOVED TODAY.

    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 INTL., INC. MF9109756

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN