BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOREIGN BODY REMOVAL CONE

    MDR report key: 1060558 · Received June 12, 2008

    Report

    Report Number
    2020394-2008-00165
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    GAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTN TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THE RETURNED SAMPLE WAS EVALUATED. REC'D WERE: ONE RECOVERY SHEATH, ONE RECOVERY CONE CATHETER WITH A DETACHED HANDLE, ONE G2 FILTER, RETURNED COMPONENTS SHOWED EVIDENCE OF EXTREME FORCE APPLIED DURING THE PROCEDURE. THE INTRODUCER SHEATH WAS RETURNED IN 2 SECTIONS. MEASUREMENTS TAKEN CONFIRMED IT WAS WITHIN SPEC. THE PROXIMAL HUB END WAS ACCORDIONED AND APPEARED TWISTED FOR APPROX 18 MM DISTAL TO THE HUB. THE ID IN THIS AREA APPEARED KINKED AND COMPRESSED. THE DISTAL TIP WAS FLARED AND HAD EVIDENCE OF DISTORTION FROM CONTACT WITH THE FILTER WIRES AND/OR HOOKS. THERE WAS NO EVIDENCE OF NECKING ON THE EXTRUSION AND THE WELD AREA WAS EVIDENT. THERE WAS A CUT MARK APPROX 5.0 CM FROM THE PROXIMAL END THAT CORRESPONDED TO THE CUT DOWN OF THE SHEATH THAT OCCURRED DURING USE. THE RECOVERY HANDLE WAS SLIGHTLY BENT. THE CONE OF THE RECOVERY CONE CATHETER HAD 2 CLAWS AND ONE STEM THAT WERE FULLY DETACHED FROM THE URETHANE. THERE WAS PARTIAL DETACHMENT OF ALL OTHER CLAWS AND PEDALS FROM THE URETHANE. THE URETHANE CONE PRESENTED WITH A SLIGHT BLUE/DISTORTION BETWEEN THE PEDALS. THERE WAS NO UNUSUAL DISTORTION OF THE ACTUAL CLAWS OR PEDALS. THE RECOVERY CONE CATHETER WAS MATED TO THE HANDLE WITH RESISTANCE. THE LENGTH WAS WITHIN SPEC. A PROOFLOAD OF 5 KG WAS ATTACHED TO THE HANDLE AND THE HANDLE DID NOT MOVE OR DETACH FROM THE SHAFT. THE RECOVERY HANDLE COULD ONLY BE REMOVED BY TWISTING, WITH MUCH MORE FORCE, AND RESISTANCE. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR HANDPIECE DETACHMENT. THE ROOT CAUSE APPEARS TO BE RELATED TO EXCESSIVE FORCE PLACED ON THE HANDLE BY THE USER. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES THE FOLLOWING: WARNING: DO NOT ATTEMPT TO REMOVE THE RECOVERY FILTER IF SIGNIFICANT AMOUNTS OF THROMBUS ARE TRAPPED WITHIN THE FILTER OR IF THE FILTER TIP IS EMBEDDED WITHIN THE VENA CAVA WALL. WHEN ATTEMPTING TO RETRIEVE A RECOVERY FILTER, ONLY USE THE RECOVERY CONE REMOVAL SYSTEM. USE OF OTHER DEVICES HAS RESULTED IN RECURRENT PULMONARY EMBOLISM. DO NOT USE EXCESSIVE FORCE WHEN MANIPULATING THE CONE. EXCESSIVE FORCE MAY DAMAGE THE CATHETER OR OTHER PARTS OF THE RECOVERY CONE. IF RESISTANCE IS EXPERIENCED DURING THE RETRIEVAL PROCEDURE, CHECK THE CAPTURED FILTER OR FOREIGN BODY AND INTRODUCER CATHETER USING FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED VENA CAVA FILTER RETRIEVAL, THE SILVER HANDLE OF THE REMOVAL SYSTEM DETACHED. THE PHYSICIAN THEN CUT THE SHEATH OPEN AND WAS ABLE TO RETRIEVE THE FILTER WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOREIGN BODY REMOVAL CONE GAE BARD PERIPHERAL VASCULAR, INC. GFSB0188

    Patients

    Seq Age Sex Outcome Treatment
    1