BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS? ULTRA

    MDR report key: 3220901 · Received July 11, 2013

    Report

    Report Number
    3005099803-2013-06493
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A VISUAL ANALYSIS OF THE RETURNED POLARIS ULTRA STENT WAS PERFORMED. THE DEVICE WAS RECEIVED WITH ITS ORIGINAL POUCH BUT THE SUTURE WAS NOT RETURNED. FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE BLADDER PIGTAIL OF THE STENT WAS DETACHED AT THE HALF (AT THE SECOND HOLE) AND IT WAS DAMAGED. THE UNIT PRESENTS THE SECOND HOLE OF THE BLADDER PIGTAIL DAMAGED WHICH IS CONSISTENTLY RELATED TO BE CAUSED BY THE SUTURE WHEN IT IS BEING PULLED OUT, THE MOST PROBABLE ROOT CAUSE WILL BE ¿HANDLING DAMAGE¿. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ISSUES WERE IDENTIFIED WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. BASED ON THIS ANALYSIS. THIS IS NOW DEEMED NON MDR REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE POLARIS ULTRA STENT WAS NOT PIGTAILED ADEQUATELY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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 POLARIS ULTRA STENT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE POLARIS ULTRA STENT WAS NOT PIGTAILED ADEQUATELY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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
    319412 POLARIS? ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061921330 15881763

    Patients

    Seq Age Sex Outcome Treatment
    1