BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACORA BIOPSY INSTRUMENT

    MDR report key: 1063380 · Received June 19, 2008

    Report

    Report Number
    2020394-2008-00169
    Event Type
    Injury
    Date Received
    June 19, 2008
    Report Date
    May 27, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K062832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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 QC TESTING. THIS LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS NOT RETURNED FOR EVAL AS IT WAS DISCARDED BY THE USER FACILITY, SO THE SAMPLE EVAL COULD NOT BE PERFORMED. BASED ON THE INFO REC'D, THE COMPLAINT IS INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU STATES: POTENTIAL COMPLICATIONS ARE THOSE ASSOCIATED WITH ANY PERCUTANEOUS REMOVAL/BIOPSY TECHNIQUE FOR TISSUE COLLECTION. POTENTIAL COMPLICATIONS ARE LIMITED TO THE REGION SURROUNDING THE BIOPSY SITE AND INCLUDE HEMATOMA, HEMORRHAGE, INFECTION, A NON-HEALING WOUND, PAIN AND TISSUE ADHERENCE TO THE BIOPSY PROBE WHILE REMOVING IT FROM THE BREAST. AS PER ROUTINE BIOPSY PROCEDURES, IT MAY BE NECESSARY TO CUT TISSUE ADHERING TO THE BIOPSY PROBE WHILE REMOVING IT FROM THE BREAST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAS BEEN NOTICING FOR SOMETIME THAT WHERE THE BIOPSY NEEDLE ENTERS THE SKIN, THE SKIN WRAPS AROUND THE NEEDLE AS IF IT TWISTING. THIS TIME HE HAD HIS TECH STRETCH THE SKIN, AT THE ENTRY SITE, TO PREVENT WRAPPING, THEN THE NEEDLE WAS POSITIONED AT THE INTENDED TISSUE COLLECTION SITE. THE VACUUM ASSISTED BREAST BIOPSY DEVICE WAS FIRED AND THE COLLECTION CHAMBER OPENED BUT DID NOT COLLECT ANY TISSUE. THE DR SAID, THE NEEDLE WAS LIKE A FISH HOOK TO REMOVE AND THAT THERE WAS 3 CM OF TISSUE WRAPPED AROUND THE NEEDLE WHEN IT CAME OUT. HE HAD TO TAKE A SCALPEL AND CUT THE SKIN TO GET THE NEEDLE OUT. HE STATED THAT IT DOES NOT HAPPEN WITH THE 10 GAUGE, JUST THE 14 GAUGE. INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACORA BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. HURJ1094

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention