BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 6156475 · Received December 8, 2016

    Report

    Report Number
    2020394-2016-01142
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 4, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084485
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER OF THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS/ISSUES WERE IDENTIFIED ASSOCIATED WITH THIS PROBLEM IN REGARDS TO PRODUCT MATERIALS OR DURING PACKAGING, MANUFACTURING OR QC INSPECTION PROCESSES. ALL NECESSARY INSPECTIONS WERE PERFORMED THROUGHOUT ALL THE MANUFACTURING, PACKAGING AND INSPECTION ACTIVITIES AND FOR RAW MATERIAL UTILIZED IN THE MANUFACTURE OF THIS LOT, IN REGARDS THE PROBLEM DESCRIBED. VISUAL INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: PRECAUTIONS: THIS PRODUCT SHOULD BE USED BY A PHYSICIAN WHO IS COMPLETELY FAMILIAR WITH THE INDICATIONS, CONTRAINDICATIONS, LIMITATIONS, TYPICAL FINDINGS AND POSSIBLE SIDE EFFECTS OF CORE NEEDLE BIOPSY, IN PARTICULAR, THOSE RELATING TO THE SPECIFIC ORGAN BEING BIOPSIED. NEVER TEST THE PRODUCT BY FIRING INTO THE AIR. DAMAGE MAY OCCUR TO THE NEEDLE/CANNULA TIP AND COULD RESULT IN PATIENT AND/OR USER INJURY. UNUSUAL FORCE APPLIED TO THE STYLET OR UNUSUAL RESISTANCE AGAINST THE STYLET WHILE EXTENDED OUT OF THE SUPPORTIVE CANNULA MAY CAUSE THE STYLET TO BEND AT THE SPECIMEN NOTCH. A BENT SPECIMEN NOTCH MAY INTERFERE WITH THE NEEDLE FUNCTION. DIRECTIONS FOR USE: BEFORE USING, INSPECT THE NEEDLE FOR DAMAGED POINT, BENT SHAFT OR OTHER IMPERFECTIONS THAT WOULD PREVENT PROPER FUNCTION. IF THE NEEDLE IS DAMAGED OR BENT, DO NOT USE. ENERGIZE (COCK) INSTRUMENT BY PULLING BACK ON THE TOP SLIDE TO WITHDRAW THE CANNULA AND LOCK IN PLACE. THEN PULL BACK ON THE BOTTOM SLIDE TO WITHDRAW THE STYLET AND LOCK IN PLACE. REMOVE PROTECTIVE NEEDLE SHEATH AND YELLOW GUARD. INSTRUMENT IS READY TO FIRE WHEN BOTH SLIDES ARE LOCKED BACK. VERIFY INSTRUMENT IS ENERGIZED (COCKED). NOTE: DO NOT PLACE FINGERS IN FRONT OF COCKING SLIDES ONCE INSTRUMENT IS ENERGIZED (COCKED). IMPEDING COCKING SLIDES' MOVEMENT WILL IMPACT FUNCTIONALITY. WHILE MAINTAINING INSTRUMENT'S POSITION AND THE NEEDLE ORIENTATION, DEPRESS THE REAR ACTUATOR BUTTON, OR PUSH THE SIDE ACTUATOR FORWARD (DIRECTION OF ARROW), TO CAUSE BOTH STYLET AND CANNULA TO AUTOMATICALLY ADVANCE. POTENTIAL COMPLICATIONS: POTENTIAL COMPLICATIONS ASSOCIATED WITH CORE BIOPSY PROCEDURES ARE SITE SPECIFIC AND INCLUDE, BUT ARE NOT LIMITED TO: HEMATOMA; HEMORRHAGE; INFECTION; ADJACENT TISSUE INJURY; PAIN; BLEEDING; HEMOPTYSIS; HEMOTHORAX; NON-TARGET TISSUE, ORGAN OR VESSEL PERFORATION; AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE BIOPSY THE FIRST SLIDE OF THE DEVICE ALLEGEDLY RELEASED WHILE PRIMING THE SECOND SLIDE. THIS ALLEGEDLY OCCURRED ON THE FOURTH SAMPLE SEQUENCE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE BIOPSY THE FIRST SLIDE OF THE DEVICE ALLEGEDLY RELEASED WHILE PRIMING THE SECOND SLIDE. THIS ALLEGEDLY OCCURRED ON THE FOURTH SAMPLE SEQUENCE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806863 MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REAP1798 00801741084485

    Patients

    Seq Age Sex Outcome Treatment
    1