BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 9110130 · Received September 24, 2019

    Report

    Report Number
    2020394-2019-03429
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    January 24, 2018
    Report Date
    September 24, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K133948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. JOURNAL ARTICLE CITATION: THURTLE, D., STARLING, L., LEONARD, K., STONE, T., & GNANAPRAGASAM, V. (2018). IMPROVING THE SAFETY AND TOLERABILITY OF LOCAL ANAESTHETIC OUTPATIENT TRANSPERINEAL PROSTATE BIOPSIES: A PILOT STUDY OF THE CAMBRIDGE PROSTATE BIOPSY (CAMPROBE) METHOD. JOURNAL OF CLINICAL UROLOGY, 11(3), 192¿199. HTTPS://DOI.ORG/10.1177/2051415818762683.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF CLINICAL UROLOGY TITLED 'IMPROVING THE SAFETY AND TOLERABILITY OF LOCAL ANESTHETIC OUTPATIENT TRANSPERINEAL PROSTATE BIOPSIES: A PILOT STUDY OF THE CAMBRIDGE PROSTATE BIOPSY (CAMPROBE) METHOD' THAT 30 MEN, AGED 18-85, UNDERWENT A TRANSPERINEAL PROSTATE BIOPSY USING THE CAMPROBE METHOD IN ORDER TO EVALUATE IT'S SAFETY AND TOLERABILITY COMPARED TO THE STANDARD TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY APPROACH. IT WAS CONCLUDED THAT THE CAMPROBE DEVICE AND METHOD APPEARS TO BE A SAFE, FEASIBLE, AND SIMPLE OUT-PATIENT TRANSPERINEAL REPLACEMENT FOR TRUSBX AND WAS WELL-TOLERATED BY THE PATIENT'S. IT OFFERS A LOWER COMPLICATION RISK AND IN THIS STUDY, THERE WAS NO EPISODES OF INFECTION OR SEPSIS. OF THE 30 PATIENTS, ONE MAN REQUIRED MEDICAL INTERVENTION FOR HIS PAIN AND WAS PRESCRIBED PAIN KILLERS FROM HIS GENERAL PRACTITIONER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905671 BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1