BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000037-1999-00024

    MDR report key: 257084 · Received December 29, 1999

    Report

    Report Number
    6000037-1999-00024
    Event Type
    Injury
    Date Received
    December 29, 1999
    Date of Event
    December 5, 1999
    Report Date
    December 6, 1999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL TIP OF THE INTRODUCER SHEATH BUCKLED AND SUBSEQUENTLY DETACHED SUBCUTANEOUSLY WHILE OBTAINING PERCUTANEOUS ACCESS DURING A NEPHROSTOMY DRAINAGE PROCEDURE. PERCUTANEOUS RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL. THE PT REMAINS ASYMPTOMATIC AND NO FURHTER RETRIEVAL ATTEMPTS HAVE BEEN SCHEDULED. FOLLOW-UP INDICATED SOME RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL OF THE SHEATH FROM THE PT. ANOTHER UNIT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO PT SEQUELAE RESULTED FROM THIS EVENT. THE DEVICE HAS NOT BEEN REC'D FOR EVAL. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. FOLLOW-UP REVEALED SOME RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL OF THE DEVICE AND THE PT'S "FLESHY" ANATOMY MAY HAVE CONTRIBUTED TO THE DIFFICULTIES ENCOUNTERED. IT WAS ALSO NOTED THAT THE SHEATH WAS "BUCKLING" DURING THE PROCEDURE PRIOR TO BREAKAGE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention