BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1003540 · Received February 26, 2008

    Report

    Report Number
    1219856-2008-00072
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 2, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE INTRA-AORTIC BALLOON (IAB) WAS RETURNED. THERE WAS BLOOD ON THE EXTERIOR SURFACES OF IAB. THE SIDEARM SUPER ARROW-FLEX SHEATH WAS ON THE BLADDER APPROXIMATELY 21.5 CM FROM THE DISTAL TIP OF THE IAB. PUMP TUBING & GUIDEWIRES WERE NOT RETURNED. THE CAL KEY & SLIDE CONNECTOR WERE ATTACHED TO THE FIBER OPTIX SENSOR (FOS) CABLE. THE FOS WAS LIGHT LEVEL TESTED & FAILED WITH INDICATION OF A BROKEN FOS. THE FOS SENSOR WAS SEATED PROPERLY IN THE GRAY HOUSING. THE RETURNED CAL KEY WAS LIGHT LEVEL TESTED WITH A KNOWN GOOD SLIDE CONNECTOR & PASSED INDICATING THE CAL KEY WAS NOT CORRUPTED. THE 6" EXTENSION LINE WAS ATTACHED TO THE LUER. THE ONE-WAY VALVE WAS ATTACHED TO THE IAB. A DIFFERENT GUIDEWIRE WAS FED THRU THE CENTRAL LUMEN WITH MINIMAL RESISTENCE ENCOUNTERED. NO BLOCKAGE OR ABNORMALITIES WERE DETECED WITH THE CENTRAL LUMEN. A VACUUM WAS PULLED ON THE IAB & HELD. THE SHEATH WAS MOVED ONTO THE CATHETER FOR FURTHER INVESTIGATION OF THE IAB. THE IAB WAS SUBMERGED & PRESSURIZED IN WATER. NO LEAKS WERE DETECTED IN THE IAB OR BLADDER. THE 6" EXTENSION WAS LEAK TESTED & PASSED. THE IAB PASSED ALL IN-HOUSE TESTING. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A DHR RE-REVIEW WAS CONDUCTED ON THE IAB & IT MET ALL SPECIFICATIONS & PASSED ALL IN-PROCESS TESTING. THERE WERE NO MANUFACTURING ABNORMALITIES ESTABLISHED BETWEEN THE DHR & THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CARDIAC CATH LAB MANAGER THAT IN 2008, THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED. ON THE NEXT DAY, THE PUMP ALARMED AND THE IAB WAS REMOVED AND REPLACED WITH ANOTHER IAB. THERE WERE NO REPORTED PATIENT COMPLICATIONS. ON ABOUT 5 DAYS LATER, AND ONE WEEK AFTER, A REQUEST WAS MADE FOR MORE INFORMATION ABOUT THE EVENT. THE STAFF AT THE FACILITY "CAN'T REMEMBER" WHAT HAPPENED, NOR CAN THEY REMEMBER THE TYPE OF ALARM THAT THE PUMP ALARMED. THEY DO REMEMBER THE PUMP ALARMING.

    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 INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention IAB PUMP (BRAND UNKNOWN)