BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNUM DISPOSABLE CORE BIOPSY NEEDLE

    MDR report key: 5016336 · Received August 19, 2015

    Report

    Report Number
    2020394-2015-01331
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 23, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FCG
    PMA / PMN Number
    K934370
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER IS UNKNOWN. VISUAL/FUNCTIONAL INSPECTION: THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE NO EVALUATION OF THE DEVICE WAS PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: PRECAUTIONS: THE INTRODUCTION OF THE NEEDLE INTO THE BODY SHOULD BE CARRIED OUT UNDER IMAGING CONTROL (ULTRASOUND, X-RAY, CT, ETC.). NEVER TEST THE INSTRUMENT WHILE THE NEEDLE IS INSTALLED IN THE INSTRUMENT. THIS COULD RESULT IN NEEDLE DAMAGE AND/OR PATIENT/USER INJURY. INSPECT THE INSTRUMENT FOR SIGNS OF DETERIORATION OR DAMAGE (CRACKING, BLISTERING, SEPARATION OF COATING, PITTING). DO NOT USE IF DETERIORATION OR DAMAGE IS OBSERVED. DIRECTIONS FOR USE: MAGNUM BIOPSY INSTRUMENT PREPARATION: ENERGIZE (COCK) THE INSTRUMENT BY PULLING BACK WITH FULL PRESSURE ON THE WHITE COCKING SLIDE TWICE UNTIL BOTH SLEDS ARE FULLY ENGAGED. NOTICE THE STATUS INDICATOR IS NOW RED. TEST THE INSTRUMENT BY FIRST MOVING THE SAFETY LEVER FROM "S" (SAFE) TO "F" (FIRE, READY) THEN DEPRESS THE TRIGGER BUTTON TO ACTUATE THE INSTRUMENT. WARNING: WHEN THE SAFETY LEVER IS IN THE "F" POSITION, THE INSTRUMENT IS READY TO FIRE. CARE SHOULD BE TAKEN NOT TO INADVERTENTLY DEPRESS THE TRIGGER AND FIRE THE DEVICE. BIOPSY PROCEDURE: POSITIONING: INTRODUCE THE NEEDLE WITH THE UNIQUE SPACER ATTACHED UNDER IMAGING CONTROL THROUGH THE INCISION UNTIL THE NEEDLE POINT IS PROXIMAL TO THE AREA TO BE BIOPSIED. WHEN THE POSITION IS CONFIRMED, ATTACH THE ENERGIZED (COCKED) BARD MAGNUM BIOPSY INSTRUMENT. TAKING CARE TO MAINTAIN THE NEEDLE ORIENTATION, ALIGN THE HOLES ON THE NEEDLE HUBS WITH THE POSTS OF THE INSTRUMENT CARRIER SLEDS. PARTIALLY CLOSE THE COVER TO MAINTAIN THE POSITION OF THE NEEDLE HUBS. COMPRESS THE ENDS OF THE SPACER TO RELEASE AND REMOVE. CLOSE THE COVER. WHILE MAINTAINING THE INSTRUMENT POSITION AND NEEDLE ORIENTATION, MOVE THE SAFETY LEVER FROM "S" (SAFE) TO "F" (FIRE, READY). DEPRESS THE TRIGGER BUTTON TO CAUSE BOTH THE STYLET AND CANNULA TO AUTOMATICALLY ADVANCE. REMOVE THE INSTRUMENT AND NEEDLE FROM THE PATIENT. POTENTIAL COMPLICATIONS: AIR EMBOLISM IS A RARE BUT SERIOUS POTENTIAL COMPLICATION OF LUNG BIOPSY PROCEDURES. RAPID DETERIORATION OF NEUROLOGICAL STATUS AND/OR CARDIAC ARRHYTHMIA MAY BE INDICATIVE OF AIR EMBOLISM. PROMPT DIAGNOSIS AND TREATMENT MUST BE CONSIDERED IF THE PATIENT EXHIBITS SIGNS OR SYMPTOMS OF AIR EMBOLISM. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    NO DEVICE, NO MEDICAL RECORDS OR NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE HAS NOT BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL CT GUIDED LUNG BIOPSY PROCEDURE OF THE RIGHT LOWER LOBE; THREE SAMPLES WERE OBTAINED WITHOUT PATIENT INCIDENT. THE PHYSICIAN STATED THAT THERE WERE NO DEFICIENCIES OR MALFUNCTIONS OF THE BIOPSY DRIVER OR NEEDLE DURING THE PROCEDURE. APPROXIMATELY ONE HOUR POST LUNG BIOPSY PROCEDURE, THE PATIENT SUFFOCATED FROM A RESPIRATORY TRACT HEMORRHAGE. THE PATIENT EXPIRED, DESPITE MEDICAL RESUSCITATION EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548877 MAGNUM DISPOSABLE CORE BIOPSY NEEDLE BIOPSY INSTRUMENT FCG BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death