BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL PERITONEAL CATHETER

    MDR report key: 7100979 · Received December 8, 2017

    Report

    Report Number
    1226348-2017-10968
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    February 17, 2014
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. IF THE PRODUCT IS RETURNED IN THE FUTUTRE, THIS COMPLAINT WILL BE RE-OPENED AND A FOLLOWUP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿NEUROENDOSCOPIC LAVAGE FOR THE TREATMENT OF INTRAVENTRICULAR HEMORRHAGE AND HYDROCEPHALUS IN NEONATES¿ PUBLISHED J NEUROSURG PEDIATRICS 13:626¿635, 2014, IT WAS REPORTED THAT IN 1 PATIENT, THE VP SHUNT HAD TO BE CONVERTED TO A VENTRICULOATRIAL SHUNT DUE TO POST-INFECTIOUS ABDOMINAL PSEUDOCYST FORMATION. PER THE ARTICLE: ¿OBJECT. NEONATAL INTRAVENTRICULAR HEMORRHAGE (IVH) MAY EVOLVE INTO POSTHEMORRHAGIC HYDROCEPHALUS AND CAUSE NEURODEVELOPMENTAL IMPAIRMENT. IN THIS STUDY, AN ENDOSCOPIC SURGICAL APPROACH DIRECTED TOWARD THE REMOVAL OF INTRAVENTRICULAR HEMATOMA WAS EVALUATED FOR ITS SAFETY AND EFFICACY. METHODS. BETWEEN AUGUST 2010 AND DECEMBER 2012 (29 MONTHS), 19 NEONATES WITH POSTHEMORRHAGIC HYDROCEPHALUS UNDERWENT NEUROENDOSCOPIC LAVAGE FOR REMOVAL OF INTRAVENTRICULAR BLOOD REMNANTS. DURING A SIMILAR LENGTH OF TIME (29 MONTHS) FROM MARCH 2008 TO JULY 2010, 10 NEONATES WERE TREATED CONVENTIONALLY, INITIALLY USING TEMPORARY CSF DIVERSION VIA LUMBAR PUNCTURES, A VENTRICULAR ACCESS DEVICE, OR AN EXTERNAL VENTRICULAR DRAIN. COMPLICATIONS AND SHUNT DEPENDENCY RATES WERE EVALUATED RETROSPECTIVELY. RESULTS. THE PATIENT GROUPS DID NOT DIFFER REGARDING GESTATIONAL AGE AND BIRTH WEIGHT. IN THE ENDOSCOPY GROUP, NO RELEVANT PROCEDURE-RELATED COMPLICATIONS WERE OBSERVED. AFTER THE ENDOSCOPIC LAVAGE, 11 (58%) OF 19 PATIENTS REQUIRED A LATER SHUNT INSERTION, AS COMPARED WITH 100% OF INFANTS TREATED CONVENTIONALLY (P < 0.05). ENDOSCOPIC LAVAGE WAS ASSOCIATED WITH FEWER NUMBERS OF OVERALL NECESSARY PROCEDURES (MEDIAN 2 VS 3.5 PER PATIENT, RESPECTIVELY; P = 0.08), SIGNIFICANTLY FEWER INFECTIONS (2 VS 5 PATIENTS, RESPECTIVELY; P < 0.05), OR SUPRATENTORIAL MULTILOCULATED HYDROCEPHALUS (0 VS 4 PATIENTS, RESPECTIVELY; P < 0.01). CONCLUSIONS. WITHIN THE PRESENTED SETUP, THE AUTHORS COULD DEMONSTRATE THE FEASIBILITY AND SAFETY OF NEUROENDOSCOPIC LAVAGE FOR THE TREATMENT OF POSTHEMORRHAGIC HYDROCEPHALUS IN NEONATES WITH IVH. THE NOMINALLY IMPROVED RESULTS WARRANT FURTHER VERIFICATION IN A MULTICENTER, PROSPECTIVE STUDY.¿ AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879709 UNK BACTISEAL PERITONEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention