BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXCESS CATHTER

    MDR report key: 795268 · Received December 13, 2006

    Report

    Report Number
    6000043-2006-00156
    Event Type
    Injury
    Date Received
    December 13, 2006
    Date of Event
    November 27, 2006
    Report Date
    November 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    PMA / PMN Number
    k924608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D AND EVALUATED BY THE MFR. THE VISUAL EXAMINATION REVEALED THAT THE CATHETER WAS TORN IN 2 PIECES. A FUNCTION EVAL FOUND THAT A 0.038 GUIDEWIRE COULD BE PASSED THROUGH THE DEVICE WITHOUT ISSUE. THE DEVICE HISTORY RECORD REVIEW REVEALED NO ANOMALIES. THE COMPLAINT HAS BEEN CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A THERAPEUTIC DRAINAGE PROCEDURE USING AN AXXCESS CATHETER IN 2006, (PT GENDER AND AGE UNK) THE CATHETER BROKE INTO 2 PIECES WHILE THE PHYSICIAN WAS WITHDRAWING THE DEVICE. THE PIECES WERE RETRIEVED BY THE PHYSICIAN. THE PT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXCESS CATHTER FGE FGE BOSTON SCIENTIFIC CORP. M0064001161 9118263

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention