BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    MDR report key: 2071162 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01606
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K955396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) RELATES TO COMPONENT (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE INTRODUCER CATHETER, ROTAVALVE SHEATH & BLUE BRAIDED SHEATH WERE RETURNED. BLOOD WAS NOTED ON THE ROTAVALVE AND THE INTRODUCER SHEATH. THE ROTAVALVE WAS NOT CONNECTED TO THE INTRODUCER SHEATH AND THE FILTER WAS NOT INSERTED IN THE CAPSULE. THE LENGTHS OF THE BLUE BRAIDED SHEATH, PLASTIC CAPSULE AND THE INTRODUCER SHEATH MET SPECIFICATIONS AND NO ANOMALIES WERE NOTED. ANALYSIS OF THE INTRODUCER CATHETER REVEALED THE PAPER SAFETY SLEEVE WAS IN PLACE AROUND THE CATHETER HANDLE AND THE TRIGGER (THUMB SWITCH) HAD NOT BEEN UNLOCKED OR MOVED DOWN THE DEPLOYMENT TRACK. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FILTER IMPLANTATION PROCEDURE, THE FILTER DEPLOYED PREMATURELY. THE INTENDED TARGET LOCATION WAS LOCATED IN THE INFERIOR VENA CAVA. WHILE ADVANCING THE STAINLESS STEEL GREENFIELD VENA CAVA FILTER THROUGH ITS SHEATH, THE FILTER DEPLOYED PRIOR TO ACTIVATING THE RELEASE MECHANISM. UPON DEPLOYMENT, THE FILTER WAS PART WAY IN THE SHEATH AND PART WAY IN THE PATIENT'S VESSEL. THE PHYSICIAN UTILIZED ONE OF THE DILATORS TO PUSH THE FILTER OUT OF THE SHEATH. THE PHYSICIAN DID NOT WANT TO USE CONTRAST AS THE PATIENT WAS IN RENAL FAILURE, BUT NEEDED TO IN ORDER TO CONFIRM THE FILTER WAS IN THE CORRECT POSITION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FILTER IMPLANTATION PROCEDURE, THE FILTER DEPLOYED PREMATURELY. THE INTENDED TARGET LOCATION WAS LOCATED IN THE INFERIOR VENA CAVA. WHILE ADVANCING THE STAINLESS STEEL GREENFIELD VENA CAVA FILTER THROUGH ITS SHEATH, THE FILTER DEPLOYED PRIOR TO ACTIVATING THE RELEASE MECHANISM. UPON DEPLOYMENT, THE FILTER WAS PART WAY IN THE SHEATH AND PART WAY IN THE PATIENT'S VESSEL. THE PHYSICIAN UTILIZED ONE OF THE DILATORS TO PUSH THE FILTER OUT OF THE SHEATH. THE PHYSICIAN DID NOT WANT TO USE CONTRAST AS THE PATIENT WAS IN RENAL FAILURE, BUT NEEDED TO IN ORDER TO CONFIRM THE FILTER WAS IN THE CORRECT POSITION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001505010 13964989

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other