BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDM VENTRICULAR CATHETER, BARIUM IMPREGNATED, 35 CM

    MDR report key: 8862176 · Received August 5, 2019

    Report

    Report Number
    2021898-2019-00306
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    June 20, 2019
    Report Date
    August 5, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    PMA / PMN Number
    K802100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. SEX: PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PETER Y. M. WOO, BEN C. F. NG, JACOB X. XIAO, DANIEL WONG, ANDREW SETO, SANDY LAM, CARMEN YIM, HONG-YIP LO, YIN-CHUNG PO, LARRY Y. W. WONG, MICHAEL W. Y. LEE, KWONG-YUI YAM, JENNY K. S. PU, KWONG-YAU CHAN, WAI-SANG POON. THE IMPORTANCE OF ASPIRIN, CATHETERIZATION ACCURACY, AND CATHETER DESIGN IN EXTERNAL VENTRICULAR DRAINAGE-RELATED HEMORRHAGE: A MULTICENTER STUDY OF 1002 PROCEDURES. ACTA NEUROCHIRURGICA 161 (2019). DOI: 10.1007/S00701-019-03978-2. ABSTRACT: BACKGROUND: EXTERNAL VENTRICULAR DRAINAGE (EVD) IS THE COMMONEST NEUROSURGICAL PROCEDURE PERFORMED IN DAILY NEUROSURGICAL PRACTICE, BUT RELATIVELY FEW STUDIES HAVE INVESTIGATED THE INCIDENCE AND RISK FACTORS OF ITS RELATED HEMORRHAGIC COMPLICATIONS. METHODS: THIS WAS A MULTICENTER RETROSPECTIVE REVIEW OF CONSECUTIVE EVD PROCEDURES. PATIENTS 18 YEARS OR OLDER WHO UNDERWENT EVD AND HAD A ROUTINE POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED WITHIN 24 HOURS WERE INCLUDED. EVD-RELATED HEMORRHAGE WAS DEFINED AS NEW INTRACRANIAL HEMORRHAGE IMMEDIATELY ADJACENT OR WITHIN THE VENTRICULAR CATHETER TRAJECTORY. THE VOLUME OF HEMORRHAGE AND THE POSITION OF THE CATHETER TIP WERE ASSESSED. A REVIEW OF PATIENT-, DISEASE-, AND SURGERY-RELATED FACTORS INCLUDING THE VENTRICULAR CATHETER DESIGN UTILIZED WAS CONDUCTED. THE BONFERRONI CORRECTION WAS APPLIEDTO THE ALPHA LEVEL OF SIGNIFICANCE (0.05) FOR MULTIVARIABLE ANALYSIS. RESULTS: NINE HUNDRED SIXTY-TWO PATIENTS UNDERWENT 1002 EVD PERFORMED BY NEUROSURGEONS IN THE OPERATING THEATER. SIXTEEN PERCENT (154) OF PATIENTSWERE ON ASPIRIN BEFORE THE PROCEDURE. THIRTY-FOUR PERCENT (333) OF PATIENTS HAD INTRACEREBRAL HEMORRHAGE, 25%(251) HAD ANEURYSMAL SUBARACHNOID HEMORRHAGE AND 16%(158) HAD TRAUMATIC BRAIN INJURY. THEMEAN DURATION FROMEVD TO THE FIRST POSTOPERATIVE CT SCAN WAS 20 ± 4 H. EVD-RELATED HEMATOMAS WERE DETECTED AFTER 81 PROCEDURES WITH A PER-CATHETER RISK OF 8.1%. MEAN HEMATOMA VOLUME WAS 1.2 ± 3.3 ML. MOST WERE LESS THAN 1 ML (GRADE I, 79%, 64), 1 TO 15 ML (GRADE II) IN 20%(16) AND A SINGLE CLOT LARGER THAN 15 ML ( GRADE III, 1%) WERE DETECTED. CLINICALLY SIGNIFICANT HEMORRHAGETHAT RESULTED IN CATHETER OCCLUSION OCCURRED IN 1.7% (17) OF PROCEDURES. MOST CATHETERS (62%, 625) WERE OPTIMALLY PLACED, I.E., ITS TIP BEING WITHIN THE IPSILATERAL FRONTAL HORN OR THIRD VENTRICLE. THREE NON-ANTIBIOTICIMPREGNATED VENTRICULAR CATHETER DESIGNS WEREUSED WITH 55% (550) BEING THE 2.2-MM INTEGRA¿ CATHETER, 14% (137) BEING THE 2.8-MM MEDTRONIC¿ CATHETER, AND 31% (315) BEING THE 3.1-MM CODMAN¿ CATHETER. INDEPENDENT SIGNIFICANT PREDICTORS FOR EVD-RELATED HEMORRHAGE WERE THE PREOPERATIVE PRESCRIPTION OF ASPIRIN (ADJUSTED OR 1.94; 95% CI 1.10¿3.44), CATHETER MALPOSITION (AOR 1.99; 95% CI 1.22¿3.23), AND USE OF THE 2.8-MM MEDTRONIC¿CATHETER (AOR 4.22; 95%CI 2.39¿7.41). CONCLUSIONS: THE PER-CATHETER RISK OF HEMORRHAGE WAS 8.1%, BUT THE INCIDENCE OF SYMPTOMATIC HEMORRHAGE WAS LOW. THE ONLY PATIENT RISK FACTOR WAS ASPIRIN INTAKE. THIS IS THE FIRST STUDY TO EVALUATE AND ESTABLISH AN ASSOCIATION BETWEEN CATHETER MALPOSITION AND CATHETER DESIGN WITH EVD-RELATED HEMORRHAGE. REPORTED EVENTS: EVD-RELATED TRACT HEMATOMAS WERE DETECTED AFTER 81 PROCEDURES (74 PATIENTS) WITH A PER-CATHETER RISK OF 8.1%. OF THE 81 PROCEDURES THAT RESULTED IN EVD-RELATED HEMATOMAS, 40 WERE ASSOCIATED WITH THE MEDTRONIC¿ CATHETER, WITH AN OD OF 2.8MM. THE MEAN TRACT HEMATOMA VOLUME WAS 1.2 ± 3.3 ML (RANGE, 0.5 TO 27.4 ML). MOST HEMATOMAS WERE LESS THAN 1 ML (GRADE I, 79%, N = 64), 1 TO 15 ML (GRADE II) IN 20% (N = 16) AND A SINGLE CASE WHERE A CLOT GREATER THAN 15 ML (GRADE III, 1%) WAS RECORDED. THE MEAN DURATION FROM EVD INSERTION TO THE 1-WEEK SCAN WAS 6 ± 18 DAYS AND THE OCCURRENCE OF TRACT HEMATOMAS AT THIS TIME POINT INCREASED TO 15.5% (N=129) OF PROCEDURES. THE MEAN HEMATOMA VOLUME AT 1-WEEK WAS 1.0 ± 2.2 ML (RANGE, 0.2 TO 20.5 ML) AND WAS NOT CONSIDERABLY DIFFERENT FROM THE INITIAL POSTOPERATIVE SCAN (P VALUE = 0.13). ONE-FIFTH OF EVD-RELATED TRACT HEMATOMAS (21%, 17), OR 1.7% OF PROCEDURES, WAS CLINICALLY SIGNIFICANT WITH ALL LEADING TO CATHETER OCCLUSION. AS A RESULT, THE PROVOKING CATHETER WAS EITHER REPLACED (13, 76% OF CASES), INSTILLED WITH UROKINASE TO RE-ESTABLISH ITS PATENCY (1, 6%), REQUIRED A CRANIOTOMY FOR CLOT EVACUATION (1,6%) OR WAS SIMPLY REMOVED (2, 12%). THE MEAN DURATION FROM EVD TO THE PERFORMANCEOF AN ADDITIONAL OPERATIVE PROCEDURE TO ADDRESS CATHETER BLOCKAGE AS A RESULT OF HEMORRHAGE WAS 4.6 ± 3.6 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653371 EDM VENTRICULAR CATHETER, BARIUM IMPREGNATED, 35 CM DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY 46118 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R