BEUDAMED
    FDA Adverse Event Other Summary report: N

    XWIRE GUIDEWIRE

    MDR report key: 1821650 · Received August 24, 2010

    Report

    Report Number
    1320894-2010-00103
    Event Type
    Other
    Date Received
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LABORATORY EXAMINATION WILL BE PERFORMED ON THE COMPLAINT PRODUCT, AS NO DEVICE WILL BE MADE AVAILABLE TO CONMED. WITHOUT THE ACTUAL COMPLAINT SAMPLE, WE CANNOT CONDUCT AN EFFECTIVE INVESTIGATION OR DETERMINE ROOT CAUSE. IN THE UNCERTAINTY AS TO THE PRODUCT NUMBER, CONMED IS UNABLE TO PERFORM A TRUE DHR/LHR REVIEW FOR THE SUSPECT DEVICE. HOWEVER, CONMED PRODUCED AN XWIRE, CATALOG NUMBER 025450S, LOT NUMBER 0811062. THE DHR/LHR FOR THIS XWIRE WAS PERFORMED AND MANUFACTURING DOCUMENTS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. IF THE DEVICE IS RETURNED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATION WILL BE PERFORMED. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS WITH THIS DEVICE. AT THE PRESENT TIME CONMED IS UNABLE TO DETERMINE IF A PATIENT INJURY OR A REPORTABLE MALFUNCTION HAS OCCURRED. A MEDICAL MALPRACTICE CLAIM IS BEING FILED WITH THE HOSPITAL AND THEREFORE CONMED IS FILING THIS MEDWATCH WITH THE FDA. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, "RECEIVED PHONE CALL FROM (B)(6) ATTORNEY REPRESENTING (B)(6) IN A MEDICAL MALPRACTICE CLAIM. SHE REPORTED "PATIENT CLAIMS PIECE OF TEFLON COATING CAME OFF DURING PROCEDURE." SHE WAS INQUIRING IF WE COULD SEND HER A SAMPLE OF AN FX WIRE, THE PART SHE GAVE ME WAS 025450F, LOT 0811062. AFTER WE SPOKE, I FOUND THIS PART NUMBER NOT FOUND IN CONMED'S SYSTEM. THE 025450S IS THE NUMBER I FOUND MOST SIMILAR (FOR AN XWIRE GUIDEWIRE). THIS COULD HAVE BEEN THAT I HEARD THE LETTER WRONG." CALLED (B)(6) BACK TO VERIFY THIS INFORMATION AND TO ASK HER FOR MORE INFORMATION SURROUNDING THE COMPLAINT SO I COULD ENTER INTO OUR SYSTEM. I RECEIVED NO REPLY TO DATE. CONMED IS NOT SURE AS TO WHETHER THIS TEFLON COATING WAS RETRIEVED BY THE PHYSICIAN OR RETAINED INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XWIRE GUIDEWIRE FX WIRE KOG CONMED CORPORATION UNKNOWN 0811062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK