BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX? PLUS

    MDR report key: 4202659 · Received October 27, 2014

    Report

    Report Number
    3005099803-2014-03512
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: STENT TORN. A VISUAL ASSESSMENT WAS PERFORMED ON THE RETURNED PERCUFLEX PLUS URETERAL STENT AND IT WAS FOUND THAT THE STENT WAS ACCORDION, SUTURE HOLE WAS TORN, AND ITS SUTURE WAS RECEIVED LOCATED IN THE RENAL PIGTAIL WITH A KNOT DIFFERENT TO THE KNOT PERFORMED DURING THE MANUFACTURING PROCESS. A MANDREL 0.038 INCHES WAS INSERTED THROUGH THE STENT AND IT PASSED PROPERLY WITHOUT RESISTANCE. IT IS MOST LIKELY THAT DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THAT LIMITED THE PERFORMANCES OF THE DEVICE, THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT". THE DEVICE HISTORY RECORD (DHR) REVIEW FOUND THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PERCUFLEX PLUS STENT COMES WITH THE GUIDE WIRE WHEN IT IS BEING PULLED BACK TO POSITION THE STENT IN THE URETER. THE PROCESS WAS REPEATED WITH THE SAME STENT THREE TIMES WITH NO SUCCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER PERCUFLEX PLUS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT RIPPED/TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684858 PERCUFLEX? PLUS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M006175253050 16765940

    Patients

    Seq Age Sex Outcome Treatment
    1