BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPEN NEUROENDOSCOPES

    MDR report key: 19939767 · Received August 8, 2024

    Report

    Report Number
    2021898-2024-00096
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    June 24, 2012
    Report Date
    August 8, 2024
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWG
    PMA / PMN Number
    K003914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ROTH J, CONSTANTINIS. SELECTIVE USE OF INTRA-CATHETER ENDOSCOPIC-ASSISTED VENTRICULAR CATHETER PLACEMENT: INDICATIONS AND OUTCOME. CHILDS NERV SYST. 2012 AUG;28(8):1163-9. DOI: 10.1007/S00381-012-1838-1. EPUB 2012 JUN 24. PMID: 22729626. ABSTRACT PURPOSE: IN A PREVIOUS WELL-CONTROLLED STUDY, ROUTINE ENDOSCOPIC-GUIDED PLACEMENT OF VENTRICULAR CATHETERS DID NOT SEEM TO DECREASE THE RATE OF SHUNT FAILURE OR PROXIMAL SHUNT MALFUNCTION. SINCE THIS STUDY WAS PUBLISHED, THIS TECHNIQUE DOES NOT SEEM TO GAIN MUCH ACCEPTANCE. HOWEVER, IN SELECTED CASES, IT MAY ASSIST IN ACCURACY AND SAFETY. WE THEREFORE HAVE ANALYZED OUR EXPERIENCE WITH SELECTIVE INTRACATHETER ENDOSCOPIC USE FOR VENTRICULAR HARDWARE PLACEMENT. METHODS: WE RETROSPECTIVELY COLLECTED CLINICAL AND RADIOLOGICAL DATA ON ALL CHILDREN UNDERGOING INTRA-CATHETER ENDOSCOPICASSISTED VENTRICULAR CATHETER PLACEMENT. RESULTS: DURING 25 MONTHS, 16 CHILDREN (AGES 3 MONTHS¿18 YEARS) UNDERWENT 18 PROCEDURES USING THE ABOVE TECHNIQUE. INDICATIONS FOR SURGERY WERE: PROXIMAL SHUNT MALFUNCTION WITH RELATIVELY SMALL VENTRICLES (TEN CHILDREN), PROXIMAL SHUNT MALFUNCTION WITH INTRAVENTRICULAR MEMBRANES (ONE CHILD), PROXIMAL SHUNT MALFUNCTION WITH DISTORTED VENTRICLES (ONE CHILD), NEW SHUNT WITH SMALL TO MEDIUM SIZED VENTRICLES (TWO CHILDREN), OR LARGE VENTRICLES AND A LOCULATED FOURTH VENTRICLE SECONDARY TO AN AQUEDUCTAL WEB (TWO CHILDREN). FOURTEEN PROCEDURES WERE TECHNICALLY SUCCESSFUL. THE CATHETER WAS PROPERLY LOCATED ON POSTOPERATIVE IMAGING IN 13 PROCEDURES. FRAMELESS NAVIGATION WAS USED IN THREE CASES. CONCLUSIONS: SELECTIVE USE OF INTRA-CATHETER ENDOSCOPICASSISTED PROXIMAL SHUNT PLACEMENT IS USEFUL AND MAY BE INDICATED IN SMALL OR DISTORTED VEN TRICLES AND IN CASES WHEN FENESTRATION OF AN INTRAVENTRICULAR MEMBRANE OR AQUEDUCTAL WEB IS INDICATED. THE MAIN VALUE OF SUCH A TECHNIQUE IS THE ABILITY TO ACCURATELY PLACE THE CATHETER TIP WITHIN DISTORTED OR SMALL VENTRICLES. LARGER SERIES ARE NEEDED TO REFINE THESE INDICATIONS. EVENTS: IN ONE CASE, THE ENDOSCOPIC VISUAL QUALITY WAS POOR AND THE PROXIMAL CATHETER WAS MALPOSITIONED LEADING TO AN EARLY SHUNT MALFUNCTION, THUS THE CHILD UNDERWENT AN ADDITIONAL EARLY PROXIMAL REVISION USING ENDOSCOPIC ASSISTANCE, WHICH WAS THIS TIME SUCCESSFUL. THERE WERE 3 SURGICAL COMPLICATIONS. TWO OF THEM WERE INTRAPARENCHYMAL CATHETER, LEADING TO IMMEDIATE REVISION. ONE OF THEM WAS ASYMPTOMATIC BLEED FROM OLD CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530992 NEUROPEN NEUROENDOSCOPES ENDOSCOPE, NEUROLOGICAL GWG MEDTRONIC NEUROSURGERY 2120-025 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R