BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 2070288 · Received April 18, 2011

    Report

    Report Number
    3002808486-2011-00017
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IVC FILTER PLACEMENT WAS PERFORMED FOR THE PATIENT WHO SUFFERED FROM DEEP-VEIN THROMBOSIS AND PULMONARY EMBOLISM. ON (B)(6) 2011, FILTER RETRIEVAL WAS PERFORMED. THE GUNTHER TULIP RETRIEVAL SET WAS INSERTED FROM RIGHT JUGULAR VEIN AND THE FILTER HOOK WAS CAUGHT BY THE LOOP TO RETRIEVE THE FILTER. HOWEVER, THE FILTER CAME OFF SINCE THE FILTER HOOK WAS NOT GRASPED ADEQUATELY AND THE OUTER SHEATH WAS WITHDRAWN FROM THE PATIENT'S BODY. THE FILTER WAS PLACED IN RIGHT JUGULAR VEIN. RIGHT INTERNAL JUGULAR VEIN WAS PUNCTURED AGAIN TO RETRIEVE THE FILTER, BUT ANGIOGRAPHY DIDN'T SHOW THE FILTER WAS IN PUNCTURED VEIN. THE PHYSICIAN NOTICED THE INITIAL PUNCTURED VEIN WAS NOT INTERNAL JUGULAR VEIN BUT OTHER THIN VEIN (THE VEIN NAME UNKNOWN). MOREOVER, THE FILTER HOOK PENETRATED BLOOD VESSEL. HE ATTEMPTED TO CUT OFF JUGULAR VEIN TO RETRIEVE THE FILTER, BUT HE WAS NOT ABLE TO DO THAT SINCE THE VEIN WAS DEEP BLOOD VESSEL. THEN A SNARE WAS INSERTED FROM RIGHT FEMORAL VEIN TO SNARE THE FILTER BODY AND TO ADVANCE THE FILTER INTO INTERNAL JUGULAR VEIN, BUT IT WAS NOT VALID. IN NEXT ATTEMPT, ONLY THE FILTER LEG ANCHORS WERE SNARED AND ADVANCED THE FILTER. BECAUSE OF THAT, TWO FILTER LEGS PENETRATED BLOOD VESSEL AROUND SUBCLAVIAN VEIN. ANGIOGRAPHY SHOWED THE FILTER HOOK WAS NOT IN INTERNAL JUGULAR VEIN. HE GAVE UP RETRIEVING THE FILTER WITH INTRAVASCULAR TREATMENT AND SURGICAL PROCEDURE WAS PERFORMED. ADDITIONAL INFORMATION WAS PROVIDED BY THE MEDICAL FACILITY ON (B)(6) 2011. SURGICAL PROCEDURE WAS PERFORMED AND THE FILTER WAS RETRIEVED UNDER GENERAL ANESTHESIA ON (B)(6) 2011. THE PATIENT IS STABLE AND NO ADVERSE EFFECT DUE TO FILTER HOOK PENETRATION WAS OBSERVED. THE PHYSICIAN INSISTED HE PUNCTURED INTERNAL JUGULAR VEIN AND ATTEMPTED TO RETRIEVE THE FILTER FROM THE VEIN. HE ALSO SAID THAT THE FILTER CAME OFF SINCE THE FILTER HOOK WAS NOT GRASPED ADEQUATELY AND THE FILTER HOOK CAME INTO COLLATERAL. HOWEVER, ANOTHER PHYSICIAN OBSERVED THE PROCEDURE AND THE RETRIEVAL SHEATH WAS NOT INSERTED INTO INTERNAL JUGULAR VEIN. THE PATIENT IS STABLE AND NO ADVERSE EFFECT DUE TO FILTER HOOK PENETRATION IS OBSERVED AFTER FILTER RETRIEVED. THE INVESTIGATION IS ONLY BASED ON THE AVAILABLE INFORMATION. NO PRODUCT OR IMAGES WERE RECEIVED. MOST LIKELY THE LOOP HAVE NOT BEEN FIRMLY SECURED BY THE Y-FITTING, THE OUTER SHEATH WAS WITHDRAWN FROM THE PATIENT'S BODY AND THEREFORE THE FILTER HOOK WAS NOT GRASPED ADEQUATELY. DURING THE FIRST RETRIEVAL ATTEMPT THE FILTER WAS MOVED AND THE TWO FILTER LEGS PENETRATED BLOOD VESSEL AROUND SUBCLAVIAN VEIN. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: SECTION 7 "PULL BACK THE LOOP UNTIL IT ENGAGES THE HOOK OF THE FILTER". SECTION 8 "HOLD THE LOOP WIRE STEADY WITH THE PIN VISE, THEN PUSH THE CLEAR Y-FITTING WITH THE CATHETER FORWARD UNTIL IT TOUCHES THE HOOK. TO SNARE THE FILTER IN THIS POSITION MAKE SURE TO FIRMLY LOCK THE SCREW OF THE CLEAR Y-FITTING ON THE WIRE LOOP." SECTION 9 "WHILE HOLDING STEADY THE RETRIEVAL LOOP SYSTEM WITH THE CLEAR Y-FITTING, PUSH FORWARD THE WHITE TUOHY-BORST SIDE-ARM ADAPTER WITH THE COAXIAL RETRIEVAL SYSTEM. THE FILTER COLLAPSES AND THE HOOKS DISENGAGE FROM THE CAVAL WALL". SECTION 10 "WHEN THE TIP OF THE COAXIAL RETRIEVAL SYSTEM IS AT THE BARBED HOOKS, LOOSEN THE HUB OF THE OUTER SHEATH, AND PUSH THE OUTER SHEATH FORWARD TO COVER THE WHOLE FILTER, AND RETRIEVE THE COMPLETE ASSEMBLY." NOTHING IN THE DESCRIPTION OF THE EVENT INDICATES THE PRESENCE OF A DEVICE FAILURE, MORE LIKELY USER TECHNIQUE CAUSED THIS ISSUE. THE COMPLAINT IS REGISTERED AND MONITORING OF SIMILAR EVENTS WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE NA E2550016

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention