BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM

    MDR report key: 11886876 · Received May 26, 2021

    Report

    Report Number
    2021898-2021-00120
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    August 27, 2019
    Report Date
    May 26, 2021
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CHENGYUAN DONG, LIANG LIU, LIGANG CHEN & LUOTONG LIU. EXTERIORIZATION OF THE DISTAL CATHETER FOR VENTRICULOPERITONEAL SHUNT PROTRUDING THROUGH THE PERITONEAL SPACE: EXPERIENCE WITH 1 CASE. BRITISH JOURNAL OF NEUROSURGERY 35 (2021). DOI 10.1080/02688697.2018.1441367. ABSTRACT VENTRICULOPERITONEAL (VP) SHUNTING IS THE MOST WIDELY USED PROCEDURE FOR DIVERTING CEREBROSPINAL FLUID (CSF) FOR HYDROCEPHALUS. MIGRATION OF THE DISTAL CATHETER OF VP SHUNTS HAS BEEN REPORTED BUT EXTRUSION THROUGH THE ABDOMINAL WALL IS RARE. WE REPORT A CASE INVOLVING DISTAL CATHETER EXTRUSION. THE CATHETER WAS EXTERIORIZED WITHOUT COMPROMISING CSF FLOW WHILE AWAITING REOPERATION. THIS CONTROLLED HYDROCEPHALUS AND ALLOWED CONFIRMATION OF CSF STERILITY PRIOR TO SHUNT REPLACEMENT. REPORTED EVENT: A (B)(6)-YEAR-OLD MAN HAD UNDERGONE VP SHUNT INSERTION 13 MONTHS PRIOR FOR COMMUNICATING HYDROCEPHALUS. SEVERAL DAYS PRIOR TO REPRESENTATION HE COMPLAINED OF MILD PERI-INCISIONAL PAIN AND HEADACHE. ON PRESENTATION THE ABDOMINAL WOUND SHOWED NO OBVIOUS ABNORMALITIES. ON THE SECOND DAY OF HIS ADMISSION THE DISTAL END OF THE SHUNT CATER APPEARED COMING OUT FROM THE ABDOMINAL PERI-INCISIONAL REGION. THE CATHETER WAS EXTERIORIZED AND DISINFECTED. A DRAINAGE KIT (MEDTRONIC, INC.) WAS CONNECTED. THE CATHETER WAS DRAINING WELL, AS OBSERVED BY DEPRESSING THE SHUNT RESERVOIR. CSF TAKEN FROM THE DISTAL CATHETER TIP WAS NORMAL WITH NO GROWTH, AND BROAD-SPECTRUM ANTIBIOTICS WERE GIVEN PROPHYLACTICALLY. THE VP SHUNT WAS REPLACED AFTER 3 WEEKS DURING WHICH NEGATIVE CSF EXAMINATION AND CULTURES WERE FOUND ON THREE OCCASIONS. THE PATIENT RECOVERED QUICKLY FROM THE OPERATION AND HIS HEADACHE DECREASED. ON REVIEW ONE MONTHS LATER HE WAS DOING WELL. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783629 CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 43103 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R