BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL CATHETER

    MDR report key: 6432434 · Received March 24, 2017

    Report

    Report Number
    1226348-2017-10183
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    October 17, 2016
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN DEVICE 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 ¿PREVENTION OF INFECTION BY ANTIBIOTIC-IMPREGNATED SHUNTS AFTER PEDIATRIC HYDROCEPHALUS TREATMENT: A SINGLE CENTER, RETROSPECTIVE STUDY IN CHINA¿, PUBLISHED CLINICAL NEUROLOGY AND NEUROSURGERY 151 (2016) 92¿95, IT WAS REPORTED THAT 10 PATIENTS DEVELOPED INFECTION POST INSERTION OF A CODMAN BACTISEAL CATHETER. PER THE ARTICLE: ¿OBJECTIVE: TO INVESTIGATE INFECTION PREVENTION BY ANTIBIOTIC-IMPREGNATED SHUNTS (AIS) RELATIVE TO CONVENTIONAL ONES AFTER PEDIATRIC HYDROCEPHALUS TREATMENT. METHODS: THIS SINGLE CENTER, RETROSPECTIVE ANALYSIS COMPRISED 807 CONSECUTIVE PEDIATRIC CASES OF HYDROCEPHALUS SHUNTING PERFORMED BY THE SAME NEUROSURGEON BETWEEN JANUARY 2001 AND FEBRUARY 2013. CONVENTIONAL AND AIS CATHETERS WERE USED IN 303 AND 504 CASES, RESPECTIVELY. STUDY OUTCOMES WERE INFECTION RATES AT 6 MONTHS (PRIMARY), AND AT 1 MONTH AND BETWEEN 1 AND 6 MONTHS (SECONDARY). AN INFANT (<1 YEAR) SUBGROUP WAS ALSO ANALYZED. RESULTS: THE AIS RELATIVE TO THE CONVENTIONAL CATHETER GROUP HAD SIGNIFICANTLY LOWER INFECTION RATES AT 6 MONTHS (1.98% [10/504] VS. 5.95% [18/303], TWO-TAILED P = 0.0046; CENTRAL NERVOUS SYSTEM: 60% AND 55.56%; ABDOMINAL: 20% AND 27.77%; WOUND: 20% AND 16.67%, RESPECTIVELY) AND 1 MONTH (0.19% [1/504]VS. 2.65% [8/303], P = 0.0023, RESPECTIVELY), BUT STATISTICALLY SIMILAR RATES BETWEEN 1 AND 6 MONTHS (1.79%[9/504] VS. 3.30% [10/303], P = 0.2296, RESPECTIVELY). IN THE INFANT SUBGROUP, AIS APPLICATION WAS ALSO ASSOCIATED WITH REDUCTION IN SHUNT INFECTION (1.49% [7/470] VS. 3.76% [10/266], P = 0.0489, RESPECTIVELY).CONCLUSION: AIS AS COMPARED TO CONVENTIONAL CATHETER USE APPEARS TO LOWER INFECTION RISK AT 6 MONTHS, MAINLY DURING THE FIRST MONTH, AFTER HYDROCEPHALUS THERAPY IN CHILDREN.¿ 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
    214667 UNK BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention