BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 5045542 · Received September 1, 2015

    Report

    Report Number
    1219856-2015-00177
    Event Type
    Death
    Date Received
    September 1, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 24, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: RETURNED FOR EVALUATION WAS A 40CC 8.0FR FOS IAB. BLOOD WAS NOTED WITHIN THE BLADDER MEMBRANE. THE DISTAL END OF THE TEFLON SHEATH WAS LOCATED APPROXIMATELY 1.5CM FROM THE DISTAL TIP OF THE CATHETER. A KINK WAS NOTED APPROXIMATELY 22.0CM FROM THE DISTAL TIP OF THE CATHETER. THE SHEATH APPEARED BUCKLED FOR A LENGTH OF 4.0CM APPROXIMATELY 7.0CM FROM THE DISTAL END OF THE SHEATH. THE BUCKLING WAS CONSISTENT WITH ATTEMPTING TO REMOVE THE CATHETER THROUGH THE SHEATH. THE KINK MAY HAVE POTENTIALLY BEEN CAUSED BY ATTEMPTED REMOVAL OF THE IAB THROUGH THE SHEATH. THE IFU STATES: "DO NOT REMOVE ARROW IAB THROUGH HEMOSTASIS SHEATH INTRODUCER OR HEMOSTASIS DEVICE. ONCE UNWRAPPED (UNFURLED), BALLOON PROFILE WILL NOT ALLOW PASSAGE THROUGH THE SHEATH AND ATTEMPTED REMOVAL IN THIS MANNER MAY RESULT IN ARTERIAL TEARING, DISSECTION OR BALLOON DAMAGE." THE FOS CONNECTOR AND CAL KEY WERE EXAMINED. THE GRAY FOS CONNECTER WAS PROPERLY SEATED IN THE HOUSING AND BOTH RETAINING TABS WERE INTACT. THE CENTER POST OF THE FOS WAS CENTERED. THE BLUE CLAMSHELL HOUSING WAS EXAMINED AND NO ABNORMALITIES WERE NOTED. THE CAL KEY WAS INTACT. THE CAL KEY AND FOS WERE CONNECTED TO THE IABP. THE CAL KEY WAS RECOGNIZED. SEE OTHER REMARKS SECTION FOR DEVICE EVALUATION CONTINUATION. OTHER REMARKS: THE PUMP STATUS WAS "LL PL" INDICATING A POTENTIAL BROKEN FIBER. THE BROKEN FIBER WAS NOTED APPROXIMATELY 2.5CM FROM THE DISTAL TIP OF THE CATHETER. THE FULL LENGTH OF THE FIBER WAS CONFIRMED PRESENT WITH NO OTHER NOTABLE BREAKS. THE IAB WAS NOT ABLE TO BE LEAK TESTED BECAUSE THE SHEATH COULD NOT BE REMOVED FROM THE CATHETER WITHOUT CAUSING FURTHER DAMAGE TO THE CATHETER. BASED ON THE TIMING OF THE EVENT, THE LEAK COULD HAVE POTENTIALLY OCCURRED BECAUSE OF ABRASIONS; HOWEVER, THE LEAK SITE WAS UNABLE TO BE LOCATED BECAUSE OF THE STATE OF THE CATHETER UPON RETURN. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF BLOOD IN HELIUM PATHWAY IS CONFIRMED BY VISUAL INSPECTION OF THE DEVICE. THE LEAK SITE WAS NOT ABLE TO BE DETERMINED BECAUSE OF THE STATE OF THE CATHETER UPON RETURN. THE SHEATH WAS UNABLE TO BE REMOVED FROM THE CATHETER WITHOUT CAUSING FURTHER DAMAGE. AS A RESULT, THE CATHETER WAS NOT ABLE TO BE LEAK TESTED. THE ROOT CAUSE OF THE LEAK IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A PATIENT WITH A TORTUOUS VASCULAR ANATOMY. WHILE IN THE OPERATING ROOM THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE PATIENT'S LEFT FEMORAL ARTERY. AFTER 12 HOURS OF INTRA-AORTIC BALLOON PUMP (IABP) THERAPY THE PUMP ALARMED HELIUM LOSS. THERE WAS NO BLOOD NOTED IN THE CATHETER. PUMPING STARTED AGAIN AND CONTINUED FOR 1/2 HOUR WHEN A SECOND HELIUM LOSS ALARM WENT OFF AND THIS TIME BLOOD WAS NOTED IN THE GAS LINE. THE BALLOON WAS REMOVED AND THE SURGEON TRIED TO PUT ANOTHER BALLOON INTO THE PATIENT, BUT DUE TO THE TORTUROUS ANATOMY THEY COULD NOT INSERT ANOTHER BALLOON. DUE TO THE EXTREME TORTUROUS ANATOMY EFFECTIVE VASCULAR ACCESS COULD NOT BE ASCERTAINED. DUE TO PATIENT'S DEPENDENCY ON IABP THERAPY AND "OTHER CLINICAL FACTORS", THE DECISION WAS TO NOT TRY AGAIN. THE SURGEON DECIDED TO TERMINATE THERAPY AT THIS TIME. THE PATIENT DIED SHORTLY THEREAFTER. THE PERFUSIONIST STATED THAT "THE PATIENT WAS CLINICALLY DEPENDENT ON IABP THERAPY AS WELL AS THERE WERE SO MANY FACTORS WORKING AGAINST THIS PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A PATIENT WITH A TORTUOUS VASCULAR ANATOMY. WHILE IN THE OPERATING ROOM THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE PATIENT'S LEFT FEMORAL ARTERY. AFTER 12 HOURS OF INTRA-AORTIC BALLOON PUMP (IABP) THERAPY THE PUMP ALARMED HELIUM LOSS. THERE WAS NO BLOOD NOTED IN THE CATHETER. PUMPING STARTED AGAIN AND CONTINUED FOR 1/2 HOUR WHEN A SECOND HELIUM LOSS ALARM WENT OFF AND THIS TIME BLOOD WAS NOTED IN THE GAS LINE. THE BALLOON WAS REMOVED AND THE SURGEON TRIED TO PUT ANOTHER BALLOON INTO THE PATIENT, BUT DUE TO THE TORTUROUS ANATOMY THEY COULD NOT INSERT ANOTHER BALLOON. DUE TO THE EXTREME TORTUROUS ANATOMY EFFECTIVE VASCULAR ACCESS COULD NOT BE ASCERTAINED. DUE TO PATIENT'S DEPENDENCY ON IABP THERAPY AND "OTHER CLINICAL FACTORS", THE DECISION WAS TO NOT TRY AGAIN. THE SURGEON DECIDED TO TERMINATE THERAPY AT THIS TIME. THE PATIENT DIED SHORTLY THEREAFTER. THE PERFUSIONIST STATED THAT "THE PATIENT WAS CLINICALLY DEPENDENT ON IABP THERAPY AS WELL AS THERE WERE SO MANY FACTORS WORKING AGAINST THIS PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578473 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYS DSP ARROW INTERNATIONAL INC. 18F15E0003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death