BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-CORE BIOPSY NEEDLE

    MDR report key: 6155925 · Received December 8, 2016

    Report

    Report Number
    1820334-2016-01417
    Event Type
    Death
    Date Received
    December 8, 2016
    Date of Event
    November 11, 2016
    Report Date
    February 8, 2018
    Manufacturer
    COOK INC
    Product Code
    MIJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH NOT REPORTED, IT IS PROBABLE THE DATE OF DEATH IS THE SAME AS THE DATE OF EVENT (B)(6) 2016. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K973565 *NUMBER COULD NOT BE ENTERED INTO FIELD. INVESTIGATION - EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WAS CONDUCTED DURING THIS INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT CONTAINS DETAILED INSTRUCTIONS FOR USE: PRECAUTION: "WHEN TEST FIRING QUICK-CORE BIOPSY NEEDLE, PLACE DISTAL BEVELED TIP OF INNER STYLET AGAINST SOLID SURFACE BEFORE ACTIVATING CUTTING CANNULA. THIS WILL PREVENT DAMAGE TO CUTTING CANNULA TIP. LUNG PUNCTURE MAY RESULT IN AN AIR EMBOLUS, WHICH COULD LEAD TO ISCHEMIA OR INFARCTION OF MAJOR ORGANS, INCLUDING THE BRAIN OR CARDIAC SYSTEM". MINIMAL INFORMATION WAS PROVIDED TO ASSIST IN THE INVESTIGATION. IT IS POSSIBLE THAT IMPROPER TECHNIQUE DURING THE PROCEDURE, DEVICE MISFIRE, DIFFICULTY IMAGING THE BIOPSY SITE, COMPLICATIONS WITH THE PATIENT'S DISEASE STATE, OR OTHER ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED MODE OF FAILURE. HOWEVER, WITHOUT ANY FURTHER INFORMATION A ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTED DATA: COMMON DEVICE NAME: INSTRUMENT, BIOPSY. PRODUCT CODE: KNW. ADDITIONAL INFORMATION: SEE ATTACHED RESPONSE TO FDA REQUEST FOR ADDITIONAL INFORMATION. THE POLICE DEPARTMENT SUSPECTED THAT THE HEMORRHAGE WAS CAUSED BY DAMAGE TO THE A6 ARTERY OF THE LIVER, AND THAT USER ERROR MAY HAVE BEEN A FACTOR. THEY ALSO STATED THAT THEY DO NOT BELIEVE THAT DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. THE LOT NUMBER FOR THIS COMPLAINT WAS NOT PROVIDED BY THE POLICE DEPARTMENT. THE POLICE DEPARTMENT DID NOT PROVIDE SUFFICIENT INFORMATION FOR COOK TO DETERMINE A FAILURE MODE OF THE DEVICE. THE AFFECTED DEVICE IS A SINGLE-USE, DISPOSABLE BIOPSY NEEDLE. THE OVERALL LIFE EXPECTANCY OF THE DEVICE IS COMMUNICATED TO USERS THROUGH THE PRODUCT LABEL, WHICH PROVIDES THE MANUFACTURE DATE AND EXPIRATION DATE FOR THE PRODUCT. PER THE LABEL, THE AFFECTED DEVICE HAS A SHELF LIFE OF FIVE (5) YEARS. THE MANUFACTURER HAS BEEN INFORMED THAT ADDITIONAL INFORMATION WILL NOT BE FORTHCOMING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A LIVER BIOPSY WAS PERFORMED AND A HEMORRHAGE OCCURRED AND THE PATIENT DIED. REPORTEDLY INTRA-ABDOMINAL HEMORRHAGE WAS SEEN AND IT IS PRESUMED THE PATIENT DEATH WAS CAUSED BY HEMORRHAGIC SHOCK. AN AUTOPSY WAS PERFORMED HOWEVER THE RESULTS HAVE NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE ORIGINAL INFORMATION REGARDING THIS EVENT WAS RECEIVED FROM THE JAPANESE CITY POLICE DEPARTMENT, WHO WERE INVESTIGATING THE EVENT DUE TO THE PATIENT DEATH. THE POLICE DEPARTMENT PROVIDED MINIMAL INFORMATION REGARDING THE EVENT, HOWEVER, THEY DID NOT BELIEVE THAT DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. MANUFACTURER REESTABLISHED COMMUNICATION WITH THE POLICE DEPARTMENT THROUGH THE COMPANY CONTACT IN JAPAN TO DETERMINE IF ANY NEW INFORMATION WAS NOW AVAILABLE. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE POLICE DEPARTMENT WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. HOWEVER, THE POLICE DEPARTMENT REAFFIRMED THEIR BELIEF THAT THE DEVICE DID NOT CONTRIBUTE TO THE EVENT AND THAT USE ERROR MAY HAVE CONTRIBUTED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806299 QUICK-CORE BIOPSY NEEDLE MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death