BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX¿ PLUS

    MDR report key: 2111669 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01829
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED BY THE COMPLAINT CONFIRMED THE PROCEDURE DATE OF (B)(4), 2011. REPORTEDLY, THE PROBLEM WAS NOTICED DURING UNPACKING, OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. ANALYSIS OF THE RETURNED PERCUFLEX PLUS URETERAL STENT REVEALED THAT THE TIP OF THE BLADDER COIL WAS DENTED. THE DENTS ARE CONSISTENT WITH THOSE CAUSED BY THE POSITIONER WHEN FORCE IS APPLIED WHEN ADVANCING DOWN A GUIDEWIRE. A .038'' GUIDEWIRE PASSED FREELY THROUGH THE STENT. THE SUTURE WAS NOT RETURNED; IT IS NOT POSSIBLE TO DETERMINE HOW THE SUTURE BECAME DETACHED. MOST LIKELY, DURING THE PREPARATION PROCESS, THE PROXIMAL TIP WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS NOTICED TO BE "DEFECTIVE". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS NOTICED TO BE "DEFECTIVE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS NOTICED TO BE "DEFECTIVE". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX¿ PLUS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA M0061752830 0014147765

    Patients

    Seq Age Sex Outcome Treatment
    1