BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMAX CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 2475341 · Received February 27, 2012

    Report

    Report Number
    1319211-2012-00015
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K080400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED COMPLAINT SAMPLE WAS DISPOSED OF BY THE USER AND NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVAL. THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED CATALOG LOT NOTED THAT THE DEVICE IN QUESTION WAS BUILT USING A SOLVENT BOND TO ADHERE THE CUFF TO THE CATHETER SHAFT. CURRENT DURAMAX ARE BUILT WITH AN ADHESIVE BOND WHICH HAS IMPROVED OVERALL BOND STRENGTH. IN COMPARING PROCESS VALIDATION RESULTS OF SOLVENT BOND AND ADHESIVE BOND IN A SIMULATED CUFF SHEARING TEST, THE AVERAGE FORCE REQUIRED TO SEPARATE THE CUFF FROM THE CATHETER WAS INCREASED 44% (22.9 LB TO 32.9 LB). IN ADDITION, CAPA (B)(4) HAS BEEN RAISED TO ADDRESS THE ROOT CAUSE FOR THIS DEFECT AND INITIATE CORRECTIVE ACTION. THIS LOT WAS BUILT PRIOR TO THE RAISING OF THE CAPA. A REVIEW ODF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED TO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    A PT OF UNK AGE AND GENDER PRESENTED FOR A CHRONIC HEMODIALYSIS CATHETER REMOVAL. THE PHYSICIAN WHO PERFORMED THE REMOVAL NOTED THAT THE INGROWTH CUFF DETACHED FROM THE CATHETER SHAFT WITH MINIMAL TRACTION ON THE CATHETER. THE PHYSICIAN HAD TO REMOVE THE CATHETER AND CUFF SEPARATELY CAUSING THE PROCEDURE TO BE PROLONGED. THE CATHETER AND CUFF WERE SUCCESSFULLY REMOVED FROM THE PT WITHOUT COMPLICATIONS THROUGH THE EXIT SITE; NO NEW INCISIONS WERE REQUIRED FOR REMOVAL. THERE WAS NO REPORT OF HARM OR INJURY TO THE PT DUE TO THIS PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMAX CHRONIC HEMODIALYSIS CATHETER CHRONIC HEMODIALYSIS CATHETER MSD ANGIODYNAMICS 536435

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention