BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 2070374 · Received April 19, 2011

    Report

    Report Number
    1820334-2011-00209
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REMOVAL OF BROKEN DEVICE IS NOT LABELED IN THE IFU. (B)(4) BREAKAGE IS NOT LABELED IN THE IFU. A PHOTO OF THE REMOVED SEGMENT OF WIRE WAS PROVIDED. QC VERIFIES; "CORRECT HOOKWIRE" 100%, "LENGTH OF HOOKWIRE AND HOOK" 100% (STEP 11), "HOOKWIRE DEPLOYS SMOOTHLY" 100%, "HOOK HAS CORRECT ANGLE" SAMPLING INSPECTION, "CLEAN AND NOT BURRED" 100%, "VERY SMOOTH TRANSITION AND CORRECT FIT BETWEEN THE CANNULA AND HOOKWIRE", 100%. THE FOLLOWING HOOK WIRE CHARACTERISTICS ARE 100% INSPECTED PER QC: LENGTH, SMOOTH DEPLOYMENT, ANGLE, AND APPEARANCE. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT WARNS "UNDER NO CIRCUMSTANCES SHOULD A HOOK WIRE ENGAGED IN TISSUE BE PULLED OUT WITHOUT SURGICAL INTERVENTION". THE IFU ALSO CAUTIONS THAT "FOLLOWING PLACEMENT OF THE HOOKWIRE, THE PORTION PROTRUDING OUTSIDE OF THE BREAST SHOULD BE BENT AND TAPED TO THE SKIN TO PREVENT INADVERTENT MOVEMENT." THE IFU ALSO ADDS "THE HOOK WIRE SHOULD BE USED AS A GUIDE FOR THE SURGEON, NOT A RETRACTOR." FROM THE EVENT DESCRIPTION THIS WOULD APPEAR TO BE AN OFF-LABEL USE. PRODUCT MANAGER STATES: PHYSICIANS WILL USE THEM TO MARK LESIONS ELSEWHERE IN THE BODY PREOPERATIVELY. I THINK TWO THINGS COULD HAVE HAPPENED HERE. THE KOPANS, DUE TO ITS TIP CONFIGURATION CAN ADVANCE DISTALLY OR PROXIMALLY DEPENDING ON SEVERAL FACTORS INCLUDING LOCATION, HANDLING, PT MOVEMENT AND TIME PRIOR TO PROCEDURE. THIS IS MOST LIKELY WHAT HAPPENED HERE, HOWEVER, A CT OR MRI SHOULD HAVE BEEN TAKEN TO ENSURE NOTHING WAS LEFT IN THE NECK ORIGINALLY. THOUGH NOT LIKELY, THE BARD AT THE TIP COULD HAVE BROKEN OFF FROM THE WIRE AND MIGRATED. THIS IS DIFFICULT TO DO HOWEVER AS THE WIRE IS FAIRLY DURABLE AND I HAVE NOT HEARD OF THIS OCCURRING WITHOUT ACCIDENTAL/INTENTIONAL CUTTING DURING RESECTION OF THE TUMOR. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTIONS ARE TAKEN DUE TO INSUFFICIENT RISK.

    Description of Event or Problem · 1

    ROOT CAUSE ANALYSIS TIMELINE FOR SENTINEL EVENT (B)(6) 2010. ON (B)(6) 2010 - PT HAD A LYMPHOSCINTIGRAPHY IN NUCLEAR MEDICINE (NM). FOLLOWING NM EXAM PT HAD WIRE LOCALIZATION IN THE ULTRASOUND SUITE. FOLLOWING ULTRASOUND EXAM PT WAS TAKEN TO SAME DAY SURGERY (SDS). PT WAS TAKEN FROM SDS TO THE OPERATING ROOM SUITE. PT PRESENTED TO THE OPERATING ROOM SUITE, DRESSING WAS REMOVED, REVEALING NO WIRE IN PLACE. OPERATING ROOM (OR) REQUESTED THAT ULTRASOUND MACHINE, TECH AND RADIOLOGIST TO THE OPERATING ROOM. ULTRASOUND TECH AND RADIOLOGIST PLACED ANOTHER WIRE FOR LOCALIZATION FOR THE SURGEON. PT PROCEEDED TO HAVE LUMPECTOMY. PT RETURNED TO RECOVERY ROOM. PT DISCHARGED HOME. ON (B)(6) 2011 - APPROX ON THIS DATE PT BEGAN EXPERIENCING SYMPTOMS FROM A MOBILE OBJECT IN THE NECK. ON (B)(6) 2011 - PT HAD A F/U ULTRASOUND OF HEAD AND NECK FOR MASS ON NECK. ON (B)(6) 2011 - PT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF FOREIGN BODY FROM RIGHT NECK PAIN. PORTION OF THE WIRE WAS REMOVED FROM THE PT'S NECK ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOPANS BREAST LESION LOCALIZATION NEEDLE DWO NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention