BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR?

    MDR report key: 3342856 · Received September 11, 2013

    Report

    Report Number
    3005099803-2013-11046
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Report Date
    August 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE RETURNED CONTOUR STENT WAS PERFORMED. THE UNIT WAS RECEIVED WITH ITS ORIGINAL POUCH BUT THE SUTURE WAS NOT RETURNED AS PART OF OVERALL VISUAL REVISION. FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS FOUND THAT THE SUTURE HOLES WERE TORN IN BETWEEN. PROCEDURE OR CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE SUTURE HOLES RIPPED/TORN, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS ¿OPERATIONAL CONTEXT.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ISSUES WERE IDENTIFIED WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR STENT WAS USED IN AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A SPLIT BETWEEN THE TWO HOLES AT THE TIP OF THE STENT NOTICED . THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS¿ CONDITION AT THE CONCLUSION OF THE PROCEDURE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR STENT WAS USED IN AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A SPLIT BETWEEN THE TWO HOLES AT THE TIP OF THE STENT NOTICED . THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS¿ CONDITION AT THE CONCLUSION OF THE PROCEDURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455213 CONTOUR? STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061802230 15602646

    Patients

    Seq Age Sex Outcome Treatment
    1