BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR-30 CC FOS

    MDR report key: 2052051 · Received March 2, 2011

    Report

    Report Number
    1219856-2011-00086
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INTRA-AORTIC BALLOON (IAB) WAS INSERTED ON SATURDAY, (B)(6) VIA THE PATIENT'S FEMORAL ARTERY. ON (B)(6), AN RN FROM THE CATH LAB DEPARTMENT PHONED THE CLINICAL SUPPORT SPECIALIST (CSS). ON (B)(6), THE SALES REPRESENTATIVE RECEIVED AN EMAIL FROM THE MANAGER OF THE CARDIAC CARE UNIT (CCU) STATING THE FOLLOWING: "TODAY WE HAD A PATIENT IN THE CCU WHO HAD AN INTRA-AORTIC BALLOON PUMP (IABP) PUT IN THE CATH LAB ON SATURDAY (B)(6). THE FELLOW WAS DISCONTINUING THE BALLOON AT THE BEDSIDE OF THE PATIENT AT 4PM AND THE BALLOON ITSELF BECAME DISCONNECTED FROM THE SPRING WIRE GUIDE (SWG), LEAVING THE END OF THE BALLOON INSIDE THE PATIENT. THE FELLOW AND RN NOTICED IMMEDIATELY AND REMOVED THE BALLOON." DETAILS OF THE EVENT: THE SALES REPRESENTATIVE PLACED A PHONE CALL AT 1700 TO THE CCU TO ASK MORE QUESTIONS AND SPOKE TO THE NURSE CARING FOR THE PATIENT. THE RN STATED THAT THE IAB WAS REMOVED WITH THE SHEATH AND NOT PULLED THROUGH IT AS FAR AS SHE COULD SEE DURING THE IAB REMOVAL. THE RN STATED THAT WHEN THE IAB WAS BEING REMOVED, IT "SPLIT AND CAME APART." THEY WERE ABLE TO GRAB THE PORTION STILL IN THE PATIENT AND THEN PULLED THAT PORTION OUT INTACT MANUALLY. THE RN CONFIRMED THAT THE PATIENT WAS DOING FINE AS FAR AS THE IAB SITE WAS CONCERNED (CONFIRMED NO BLEEDING, NO HEMATOMA, PULSES PRESENT, CIRCULATION INTACT AND NO OTHER SIGNS OR SYMPTOMS OF ANYTHING WRONG FOR THE PATIENT). THERE WAS NO REPORTED PATIENT DEATH OR INJURY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT OUTCOME IS LISTED AS FINE. THERE WERE NO ADDITIONAL COMPLICATIONS RELATED TO THE IAB REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR-30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL, INC. NA

    Patients

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