BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCERTA¿

    MDR report key: 2941457 · Received February 4, 2013

    Report

    Report Number
    3005099803-2013-00423
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. VISUAL INSPECTION OF THE RETURNED ASCERTA STENT REVEALED NO ISSUE WITH THE COMPLAINT DEVICE. BOTH RENAL AND BLADDER PIGTAILS WERE PROPERLY FORMED AND DID NOT SHOW ANY ANOMALY OR DEFECT. A 0.038 GUIDEWIRE WAS PASSED THROUGH THE STENT AND BOTH PIGTAILS RECOVERED THEIR SHAPE APPROPRIATELY. THE CIRCUMSTANCES UNDER WHICH THE PIG TAIL COULD NOT BE FORMED PROPERLY DURING THE PROCEDURE CANNOT BE DETERMINED SINCE THE RENAL AND BLADDER PIGTAILS WERE FOUND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ASCERTA URETERAL STENT WOULD NOT STAY COILED DURING THE PLACEMENT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ASCERTA URETERAL STENT WOULD NOT STAY COILED DURING THE PLACEMENT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46759 ASCERTA¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061456140 0015385726

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR