BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVER-THE-WIRE EMBOLECTOMY CATHETER

    MDR report key: 1346808 · Received February 27, 2009

    Report

    Report Number
    1220948-2009-00004
    Event Type
    Other
    Date Received
    February 27, 2009
    Date of Event
    October 31, 2008
    Report Date
    February 26, 2009
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DXE
    PMA / PMN Number
    K022145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP DESCRIPTION OF EVENT WAS REVIEWED AND DID NOT CORRELATE TO THE FDA FORM CONCERNING THE SUSPECT DEVICE. THE DESCRIPTION OF THE EVENT DISCUSSES THE INTENDED PROCEDURE WAS A CHOLECYSTECTOMY WITH AN INTRAOPERATIVE CHOLANGIOGRAM. THE SUSPECT DEVICE USED WAS AN OVER-THE-WIRE EMBOLECTOMY CATHETER INDICATED FOR THE REMOVAL OF SOFT EMBOLI AND THROMBI. IN ACCORDANCE TO THE INDICATIONS FOR USE FOR THE OTW EMBOLECTOMY CATHETER, THIS DEVICE IS NOT INTENDED FOR BILE DUCT EXPLORATION. THE HOSP WAS CONTACTED AND THEY ARE INVESTIGATING IN WHAT CONTEXT THE DEVICE WAS USED AND HOW THE TIP OF THE DEVICE BROKE OFF. IN ADDITION, THE ORIGINAL REPORT STATES THAT THE DEVICE IS AVAILABLE FOR EVAL. THE HOSP IS ALSO LOOKING INTO WHETHER THE DEVICE IS STILL AVAILABLE FOR EVAL. A LOT HISTORY INVESTIGATION WAS PERFORMED ON LOT OTW1275. IT WAS FOUND THAT THERE WERE NO NON-CONFORMITIES FOUND DURING THE MFR OF THIS PARTICULAR LOT. QC POST-STERILIZATION BALLOON PULL TESTING WAS PERFORMED AND RETRIEVED. THE LOT WAS FOUND TO PASS ABOVE CURRENT PULL TESTING SPECIFICATIONS. A FOLLOW-UP WILL BE SENT WITH ANY FINDINGS FROM THE INVESTIGATION AND EVAL.

    Description of Event or Problem · 1

    DATE OF EVENT WAS 2008. THE HOSP REPORTED THE EVENT TO THE FDA ON 12/19/08. FDA FORWARDED THE REPORT ON 1/23/09. LEMAITRE VASCULAR RECEIVED THE LETTER ON 1/26/09. ATTACHED IS THE REPORT RECEIVED FROM FDA. THE FOLLOWING IS THE DESCRIPTION SENT BY THE HOSP: EVENT DESCRIPTION: CATHETER FRACTURED WHILE ATTEMPTING TO PERFORM COMMON BILE DUCT EXPLORATION. A 1CM PORTION WITH THE BALLOON HAD BROKEN OFF. DID THE EVENT INVOLVED AND ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LAPAROSCOPIC CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAM, EXTENSIVE LYSIS OF ADHESIONS, ATTEMPTED COMMON BILE DUCT EXPLORATION WITH PRUITT CATHETER. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER-THE-WIRE EMBOLECTOMY CATHETER DUAL LUMEN EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR NA OTW1275

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other