BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER

    MDR report key: 11848810 · Received May 19, 2021

    Report

    Report Number
    3009211636-2021-00112
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 19, 2021
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SALVAGE OF MALFUNCTIONING PERITONEAL DIALYSIS CATHETERS: AN ALGORITHM FOR RECANALIZATION AND REPOSITIONING SOURCE: JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY ACCEPTED DATE: 14 MARCH 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE OBSERVATIONAL STUDY EVALUATED ALL PATIENTS WITH PD (PERITONIAL DIALYSIS) CATHETER MALFUNCTION THAT WERE REFERRED FOR FLUOROSCOPIC INTERVENTION WITH REPORTED CATHETER INFLOW AND/OR OUTFLOW OBSTRUCTION WITHIN A 10-MONTH PERIOD (BETWEEN OCTOBER 2018 AND AUGUST 2019). THIS STUDY EVALUATED TWO MAIN CLASSES OF MECHANICAL CATHETER FAILURE: MALPOSITION AND CATHETER OBSTRUCTION. ALL FORTY PATIENTS HAD THE SAME MAKE AND MODEL OF PD CATHETER WITH DOCUMENTED CATHETER MALFUNCTION: INFLOW OBSTRUCTION IN 5% (2/41), OUTFLOW OBSTRUCTION IN 63% (26/41), BOTH INFLOW AND OUTFLOW OBSTRUCTION IN 29% (12/41), AND PAIN WITHOUT INFLOW OR OUTFLOW OBSTRUCTION IN 2% (1/41). THE MEAN TIME BETWEEN PD CATHETER INSERTION AND PRESENTATION TO THE INTERVENTIONAL RADIOLOGY SUITE WAS 317 DAYS (RANGE 21-1719 DAYS). MALPOSITIONED CATHETERS WERE IDENTIFIED DURING FLUOROSCOPY OR BY PREVIOUS IMAGING SUCH AS AN ABDOMINAL RADIOGRAPH OR CT (COMPUTERIZED TOMOGRAPHY). IF FAILURE OCCURRED, THE PD CATHETERS WERE SALVAGED SURGICALLY VIA MINI-LAPAROTOMY AND/OR THE PATIENT WAS SWITCHED TO HEMODIALYSIS. TWO PATIENTS DEVELOPED COMPLICATIONS. ONE WAS AN EXIT SITE INFECTION AND THE OTHER WAS CULTURE-NEGATIVE PERITONITIS. BOTH INSTANCES WERE TREATED WITH ANTIBIOTICS PER PROTOCOL WITHOUT HOSPITALIZATION OR FURTHER COMPLICATIONS. ARTICLE : SALVAGE OF MALFUNCTIONING PERITONEAL DIALYSIS CATHETERS : AN ALGORITHM FOR RECANALIZATION AND REPOSITIONING / AUTHORS : LI P, CHOO D, DEVED V, SHAH N, SHURRAW S, ZUIDEMA S, SAMJI R, YEAR 2021,JOURNAL OF VASCULAR & INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743914 PERITONEAL CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. PERITONEAL CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention