BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA ASPIRATION TUBE

    MDR report key: 6046585 · Received September 29, 2016

    Report

    Report Number
    MW5065522
    Event Type
    Death
    Date Received
    September 29, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 20, 2016
    Manufacturer
    PENUMBRA
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN INTERVENTIONAL RADIOLOGY FOR SACRIFICE OF THE RIGHT VERTEBRAL ARTERY UNDER GENERAL ANESTHESIA. FIRST, A DIAGNOSTIC CEREBRAL ANGIOGRAM WAS PERFORMED IN ORDER TO ASSESS ARTERIAL ANATOMY. FOLLOWING THE ANGIOGRAM, THE RIGHT VERTEBRAL ARTERY WAS COILED USING A PENUMBRA POD COIL 30CM (REF # RBYPOD4, LOT # F70305) AND A PENUMBRA FILLING COIL 60C (REF # RBYPODJ60, LOT # F69547). THE RIGHT VERTEBRAL ARTERY WAS CHOSEN TO BE SACRIFICED IN ORDER TO AID IN SURGICAL RESECTION OF AN AVM. DURING THE INITIAL DIAGNOSTIC ANGIOGRAM, IT WAS NOTED THAT THERE WERE ADDITIONAL VESSELS THAT REQUIRED EMBOLIZATION ORIGINATING FROM THE LEFT ECA. PLANNED TO ALSO EMBOLIZE THESE VESSELS IN ORDER TO AID IN FUTURE SURGICAL RESECTION. A PENUMBRA 30CM PACKING J-COIL (LOT # F70345, REF # RBYPODJ30) WAS SELECTED FOR USE TO EMBOLIZE THE FEEDING VESSELS ORIGINATING FROM THE LEFT ECA. DURING INSERTION OF THE COIL, THE COIL SPONTANEOUSLY DETACHED FROM THE GUIDE-WIRE. ATTEMPT WAS MADE TO REMOVE THE MALPOSITIONED COIL IN ORDER TO AVOID IT CAUSING HARM TO THE PATIENT. MULTIPLE ATTEMPTS WITH MULTIPLE DIFFERENT METHODS WERE USED TO TRY AND REMOVE THE COIL. HOWEVER, DUE TO THE SOFT NATURE OF THE COIL, THE ENTIRE COIL WAS NOT ABLE TO BE REMOVED. DEVICES USED IN ATTEMPT TO REMOVE THE COIL WERE THE FOLLOWING: AMPLATZ GOOSE NECK SNARE (LOT # 9760130, REF # SK201), AMPLATZ GOOSE NECK SNARE (LOT # A193320, REF # SK401), ALLIGATOR RETRIEVAL DEVICE (LOT # A004819, REF # FA-88810-20), AND PENUMBRA ASPIRATION SYSTEM (TUBING LOT # F69551 ,REF # PST2, CANISTER LOT # F71474, REF #PAPS2). DECISION MADE TO TERMINATE THE PROCEDURE AFTER REMOVING SOME OF THE COIL. THE PATIENT WAS THEN BROUGHT TO CT FOR A CT SCAN OF THE HEAD, TRANSPORTED TO THE ANESTHESIA RECOVERY UNIT, AND FINALLY TO THE ICU FOR MONITORING. THE MULTIPLE ATTEMPTS AT REMOVING THE COIL AND THE OVERALL PROCEDURE REQUIRED THE USE FOR 4771 MGY OVER 133.3 MIN IN RADIATION DOSE/TIME THAT THE PATIENT RECEIVED. DATE OF INITIAL REPORT WAS MADE ON (B)(4) 2016. THIS REPORT ALSO UPDATED TO SHOW PATIENT'S DEATH ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640727 PENUMBRA ASPIRATION TUBE ASPIRATOR TUBING DXE PENUMBRA FB9551
    640728 PENUMBRA ASPIRATION CANISTER CANISTER DXE PENUMBRA F71474
    640826 PENUMBRA PACKING COIL J-SOFT 30 CM PENUMBRA COIL J-SOFT HCG PENUMBRA REF # RBYPODJ30 F7035
    640827 AMPLATZ GOOSE NECK SNARE NECK SNARE DQY 9760130
    640828 AMPLATZ GOOSE NECK SNARE NECK SNARE DQY H004819
    640829 ALLIGATOR RETRIVAL DEVICE RETRIVAL DEVICE DQY H004819

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| R