BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASHOLD BIOPSY NEEDLE (DISPOS)

    MDR report key: 9136908 · Received September 30, 2019

    Report

    Report Number
    3004608878-2019-01034
    Event Type
    Injury
    Date Received
    September 30, 2019
    Report Date
    September 4, 2019
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HAW
    PMA / PMN Number
    K032054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT AND SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE THE DHR REVIEW CANNOT BE PERFORMED. NO NEW DESIGN OR MANUFACTURING TRENDS WERE IDENTIFIED. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION ALTHOUGH SEVERAL REQUESTS FOR ADDITIONAL INFORMATION WERE SENT. THE REPORTED COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBERS: 3004608878-2019-01035, 3004608878-2019-01036, AND 3004608878-2019-01037. HTTPS://DOI.ORG/10.1016/J.CLINEURO.2018.09.020.

    Description of Event or Problem · 1

    THIS IS 1 OF 4 REPORTS. CLINICAL NEUROLOGY AND NEUROSURGERY (2017) PUBLISHED "HOW IS STEREOTACTIC BRAIN BIOPSY EVOLVING? A MULTICENTRIC ANALYSIS OF A SERIES OF 421 CASES TREATED IN ROME OVER THE LAST SIXTEEN YEARS". OBJECTIVE: IN RECENT DECADES, FRAME-BASED (FBB) AND FRAME-LESS STEREOTACTIC BRAIN BIOPSY (FLB) HAVE PLAYED A CRUCIAL ROLE IN DEFINING THE DIAGNOSIS AND MANAGEMENT OF EXPANDING INTRACRANIAL LESIONS IN CRITICAL AREAS. DURING THE SAME PERIOD, THERE HAVE BEEN SIGNIFICANT ADVANCES IN DIAGNOSTIC IMAGING, A SHIFT IN SURGICAL STRATEGIES TOWARDS EXTENSIVE RESECTION IN GLIOMAS AND NEW MOLECULAR CLASSIFICATION OF BRAIN TUMORS. TAKING THESE ADVANCES INTO ACCOUNT, THE AUTHORS HAVE EVALUATED WHETHER SIGNIFICANT CHANGES HAVE OCCURRED OVER THE LAST SIXTEEN YEARS OF THEIR CLINICAL PRACTICE IN TERMS OF FREQUENCY, INDICATIONS, TARGET SELECTION, AND THE HISTOLOGIC RESULTS OF STEREOTACTIC BRAIN BIOPSY (SBB) PROCEDURES. PATIENTS AND METHODS: THEY ANALYZED A SERIES OF 421 SBB CASES TREATED BETWEEN JANUARY 2002 AND JUNE 2017 IN THREE MAJOR NEUROSURGICAL INSTITUTES IN ROME, SERVING A TOTAL OF 1.5 MILLION PEOPLE. WITHIN THIS SERIES, 94.8% OF PATIENTS UNDERWENT FBB USING THE COSMAN-ROBERTS-WELLS (CRW ¿ INTEGRA) STEREOTACTIC FRAME, WHILE, MORE RECENTLY, FLB WAS PERFORMED IN 5.2% OF CASES USING THE STEALTHSTATION NAVIGUS FRAMELESS PASSIVE BIOPSY SYSTEM (MEDTRONIC, INC.). ALL SELECTED PATIENTS UNDERWENT STEREOTACTIC BIOPSY WITH A NASHOLD NEEDLE THROUGH A STANDARD BURR HOLE. THE ENTIRE PERIOD UNDER CONSIDERATION, RUNNING FROM 2002 TO 2017, HAS BEEN FURTHER STRATIFIED INTO FOUR-YEAR TIME-FRAMES (2002¿2005, 2006¿2009, 2010¿2013, 2014¿2017) FOR THE PURPOSE OF ANALYSIS. THE MEDIAN AGE OF THE PATIENTS WAS 63.5 (RANGE 5¿82 YEARS). 216 WERE MALE AND 205 WERE FEMALE. RESULTS: THE DIAGNOSTIC YIELD WAS 97%. FINAL DIAGNOSES REVEALED TUMORS IN 90% OF CASES AND NON-NEOPLASTIC MASSES IN 7%, WHILE 3% OF CASES WERE NOT CONCLUSIVE. OVERALL MORBIDITY WAS 3% (13/421): TRANSIENT NEUROLOGICAL DEFICITS OCCURRED IN 6 CASES, WHILE 7 PATIENTS SUFFERED PERMANENT DEFICITS. SYMPTOMATIC CEREBRAL HEMORRHAGE REQUIRING CRANIOTOMY OCCURRED IN SIX CASES: THREE GLIOBLASTOMA (GBM), TWO PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA (PCNSL), AND ONE ABSCESS. POST-OPERATIVE MORTALITY RATE, AS A DIRECT CONSEQUENCE OF SUCH HEMORRHAGES AFTER BIOPSY PROCEDURES, WAS 0.7% (3/421): ONE GBM, ONE LYMPHOMA, AND ONE ABSCESS. INTRA-OPERATIVE FROZEN SECTIONS WERE MADE IN 78% OF BIOPSIES. IN OUR THREE INSTITUTES, THE NUMBER OF SBBS DECREASED STEADILY THROUGHOUT THE TIME-FRAMES UNDER CONSIDERATION. THEY HAVE ALSO OBSERVED A STATISTICALLY SIGNIFICANT REDUCTION IN BIOPSY PROCEDURES IN LOBAR LESIONS, WHILE THOSE PERFORMED ON THE BASAL GANGLIA INCREASED AND THE NUMBER OF SBBS OF MULTIPLE MASSES AND LESIONS OF THE CORPUS CALLOSUM REMAINED STABLE. PRIMARY CENTRAL NERVOUS SYSTEM DIAGNOSIS OF LYMPHOMAS (PCNSL) WAS THE SOLE DIAGNOSIS WHOSE INCIDENCE INCREASED SIGNIFICANTLY. CONCLUSIONS: OVER THE LAST SIXTEEN YEARS, WE HAVE WITNESSED A SIGNIFICANT DECREASE IN SBB PROCEDURES AND A MODIFICATION IN TARGET SELECTION AND HISTOLOGIC RESULTS. DESPITE THE SIGNIFICANT EVOLUTION OF NEUROIMAGING, AN ACCURATE NON-INVASIVE DIAGNOSIS OF INTRACRANIAL EXPANDING LESIONS HAS NOT YET BEEN ACHIEVED. FURTHERMORE, THE MOST RECENT WHO CLASSIFICATION OF BRAIN TUMORS (2016), WHICH INCORPORATES MOLECULAR AND MORPHOLOGICAL FEATURES, HAS BOOSTED THE NEED FOR MOLECULAR PROCESSING OF TISSUE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931072 NASHOLD BIOPSY NEEDLE (DISPOS) N/A HAW INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1