BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 14279480 · Received May 4, 2022

    Report

    Report Number
    9612501-2022-00718
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    December 10, 2019
    Report Date
    May 3, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    KOIDE, Y., OSAKO, T., KAMEDA, M., IHORIYA, H., YAMAMOTO, H., FUJISAKI, N., AOKAGE, T., YUMOTO, T., DATE, I., NAITO, H., NAKAO, A. HUGE ABDOMINAL CEREBROSPINAL FLUID PSEUDOCYST FOLLOWING VENTRICULOPERITONEAL SHUNT: A CASE REPORT. JOURNAL OF MEDICAL CASE REPORTS. 2019. (13) 1-4. HTTPS://DOI.ORG/10.1186/S13256-019-2308-0 INTRODUCTION: ABDOMINAL PSEUDOCYSTS COMPRISING CEREBROSPINAL FLUID ARE AN UNCOMMON BUT SIGNIFICANT COMPLICATION IN PATIENTS WITH VEN TRICULOPERITONEAL SHUNT. WE PRESENT A SUCCESSFULLY TREATED (B)(6)-YEAR-OLD BOY WITH A HISTORY OF VENTRICULOPERITONEAL SHUNTING AND A HUGE ABDOMINAL CEREBROSPINAL FLUID PSEUDOCYST. CASE PRESENTATION: A (B)(6)-YEAR-OLD (B)(6) BOY PRESENTED WITH A DETERIORATED CONSCIOUSNESS AND A PALPABLE AND ELASTIC LARGE LOWER ABDO MINAL MASS. COMPUTED TOMOGRAPHY OF HIS ABDOMEN DEMONSTRATED A COLLECTION OF HOMOGENOUS LOW-DENSITY FLUID NEAR THE CATHETER TIP OF THE VENTRICULOPERITONEAL SHUNT. CEREBRAL COMPUTED TOMOGRAPHY REVEALED AN INCREASED VENTRICULAR SIZE. BASED ON THE CLINICAL DIAGNOSIS OF ABDOMINAL PSEUDOCYST, THE PERITONEAL SHUNT CATHETER WAS SECURED AND DIVIDED INTO TWO PARTS BY CUTTING IT ON THE CHEST; THEN, THE PROXIMAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS EXTERNALIZED FOR EXTRAVENTRICULAR DRAINAGE. THE CYST WAS PERCUTANEOUSLY ASPIRATED WITH ULTRASOUND GUIDANCE, AND THE DISTAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS REMOVED. THE DISTAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS REINSERTED IN ANOTHER POSITION INTO HIS ABDOMEN AFTER 3-WEEK EXTRAVENTRICULAR DRAINAGE MANAGEMENT. CONCLUSION: EMERGENCY PHYSICIANS SHOULD KNOW ABOUT THIS POTENTIAL COMPLICATION AS AN IMPORTANT DIFFERENTIAL DIAGNOSIS RESULTING FROM ACUTE ABDOMINAL COMPLAINTS IN PATIENTS WITH VENTRICULOPERITONEAL SHUNTS. REPORTED EVENTS PATIENT PRESENTING WITH VOMITING, CEPHALALGIA, APATHY, HEADACHE, APPETITE LOSS FOR 7 DAYS, AND AN INDURATED ABDOMINAL MASS REVISION SURGERY WAS PERFORMED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566207 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other