BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL CATHETER

    MDR report key: 6431829 · Received March 24, 2017

    Report

    Report Number
    1226348-2017-10180
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 1, 2017
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE, UDI UNAVAILABLE. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INTRAOPERATIVE FLUOROSCOPY FOR VENTRICULOPERITONEAL SHUNT PLACEMENT¿, PUBLISHED WORLD NEUROSURG. (2016) 86:71-78. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2015.08.072, IT WAS REPORTED THAT IN THE X-RAY GROUP WHERE BACTISEAL CATHETERS WERE USED, THE FOLLOWING EVENTS WERE REPORTED: 2 EVENTS OF INFECTION, 1 INTRAPARENCHYMATOUS CONTUSION AND 1 EVENT OF DISTAL CATHETER DISLOCATION. PER THE ARTICLE: ¿CATHETER MALPOSITIONING IS ONE OF THE MOST FREQUENT CAUSES OF VENTRICULOPERITONEAL SHUNT DYSFUNCTION AND REVISION SURGERY. MOST INTRAOPERATIVE TOOLS USED TO IMPROVE THE ACCURACY OF CATHETER INSERTION ARE TIME CONSUMING AND EXPENSIVE OR DO NOT DISPLAY THE FINAL POSITION. WE EVALUATE THE USEFULNESS OF INTRAOPERATIVE FLUOROSCOPY TO DECREASE CATHETER MALPOSITIONING, AND DEFINE RADIOLOGICAL LANDMARKS TO IDENTIFY THE CORRECT LOCALIZATION¿. INTRAOPERATIVE FLUOROSCOPY IS EASY TO PERFORM AND IS A RELIABLE METHOD TO ASSESS CORRECT CATHETER POSITIONING. BASED ON ITS PREDICTIVE VALUE, CORRECTIONS OF MALPOSITIONED VENTRICULAR CATHETERS CAN BE PERFORMED DURING THE SAME PROCEDURE. THE USE OF INTRAOPERATIVE FLUOROSCOPY DECREASES EARLY SURGICAL REVISIONS IN VENTRICULOPERITONEAL SHUNT TREATMENT.¿ NONE OF THE PATIENTS IN THE X-RAY GROUP REQUIRED REVISION FOR MALPOSITIONING. TREATMENT OF THE CATHETER DISLOCATION WAS REPORTED AS A DEVICE REVISION. THERE WAS NO TREATMENT REPORTED FOR THE INFECTION OR CONTUSION EVENTS. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214471 UNK BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention