BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR POLARIS URETERAL STENT

    MDR report key: 1790613 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03395
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K010002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DETAILED DEVICE ANALYSIS OF THE RETURNED AXXCESS CATHETER REVEALED SCRATCH/SCRAPE MARKS TO THE TIP OF THE CATHETER. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. THE EVENT IS CONSIDERED TO BE NON-REPORTABLE BASED ON THE REPORT THAT THE TIP OF THE CATHETER WAS SCRATCHED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. (B)(4): ALTHOUGH EXPECTED, THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: EVENT DATE UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA NSH KIT WAS BEING USED IN A STENTING PROCEDURE (PATIENT IDENTIFIER, AGE, GENDER, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT," THE TIP OF THE URETER CATHETER WHICH WAS SUPPLIED WITH A STENT KIT HAD BEEN BROKEN." THE PATIENT WAS REPORTED TO BE IN "GOOD" CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    NOTE: EVENT DATE UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA NSH KIT WAS BEING USED IN A STENTING PROCEDURE (PATIENT IDENTIFIER, AGE, GENDER, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT," THE TIP OF THE URETER CATHETER WHICH WAS SUPPLIED WITH A STENT KIT HAD BEEN BROKEN." THE PATIENT WAS REPORTED TO BE IN "GOOD" CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR POLARIS URETERAL STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M006193132090

    Patients

    Seq Age Sex Outcome Treatment
    1