BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL-TRANSEND 135-CM

    MDR report key: 1051332 · Received May 23, 2008

    Report

    Report Number
    2939204-2008-00204
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORAITON
    Product Code
    DQX
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ALLEGING THAT PEELING OF THE GUIDEWIRE OCCURRED INSIDE THE PATIENT. RESULTS: OTHER. SUMMARY OF DEVICE EVALUATION: A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED ON THIS LOT, AND NO YIELD OR COMPONENT ISSUES THAT ARE RELEVANT TO THIS EVENT WERE IDENTIFIED AT THE TIME OF MANUFACTURE OF THIS LOT. A SEARCH IN THE COMPLAINT DATABASE WAS PERFORMED AND NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS LOT. THE GUIDEWIRE [DEVICE IN QUESTION] WAS RETURNED TO THE MANUFACTURER INSIDE A NON-ORIGINAL OPEN POUCH - THE WIRE WAS REMOVED FROM THE PACKAGING AND VISUALLY EXAMINED. IT WAS OBSERVED THAT THE PTFE COATING ON THE GUIDEWIRE WAS DEEPLY SCRATCHED AT 3 CM AND 10 CM FROM ITS PROXIMAL END. PEELING OF THE PTFE WAS NOTED AT 37 CM OF THE PROXIMAL. PTFE ADHESION TEST WAS PERFORMED ADJACENT TO THE OBSERVED ABRADED PTFE AND NO PEEL OFF OCCURRED. DEVICE EVALUATION: NO DIMENSIONAL PROBLEMS OR DEFECTS WERE FOUND WITHIN THE WIRE THAT COULD CAUSE THE RESISTANCE FELT DURING USE. IT WAS REPORTED THAT THE USER FELT THE SYSTEM WAS TIGHT DURING USE AND PEELING OF THE PTFE WAS NOTED AFTER RETRIEVAL OF THE DEVICE. IT CAN BE CONCLUDED THAT THE SCRATCHED AND ABRADED PTFE WAS CAUSED BY FRICTION BETWEEN THE GUIDEWIRE AND CATHETER. THE FOLLOWING IS A PRECAUTION REFERENCE IN THE DIRECTIONS FOR USE (DFU) FOR THE PRODUCT: "DUE TO THE VARIATIONS OF CERTAIN CATHETER TIP INNER DIAMETERS, ABRASION OF THE HYDROPHILIC COATING MAY OCCUR DURING MANIPULATION. IF ANY RESISTANCE IS FELT DURING INTRODUCTION OF THE CATHETER, USE OF A DIFFERENT CATHETER MAY BE WARRANTED. EXCESSIVE TIGHTENING OF THE TORQUE DEVICE ONTO THE WIRE MAY RESULT IN ABRASION OF THE COATING ON THE WIRE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT A CUSTOMER ENCOUNTERED DIFFICULTIES DURING USE OF A GUIDEWIRE: FRICTION WAS ENCOUNTERED WHEN THE PHYSICIAN TRIED TO ADVANCE THE CATHETER OVER THE GUIDEWIRE. THE PHYSICIAN REMOVED THE GUIDEWIRE FROM THE PATIENT, AND COMPLETED THE PROCEDURE WITH A NEW DEVICE. IT WAS REPORTED THAT "IT SEEMED THE COATING OF WIRE WAS PEELED OFF." PATIENT CONDITION WAS REPORTED AS "GOOD" WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL-TRANSEND 135-CM DQX: GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORAITON 46-810 11236116

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR