BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR POLARIS URETERAL STENT

    MDR report key: 1994236 · Received February 17, 2011

    Report

    Report Number
    3005099803-2011-00339
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K010002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT CALCIFIED RESIDUE WAS PRESENT ON THE STENT. THE STENT DID SHOW SIGNS IT HAD BEEN IMPACTED WITH A LASER AS THE DISTAL (RENAL) CURL WAS CHARRED IN A FEW LOCATIONS. THE STENT WAS ALSO KINKED ADJACENT TO THE CHARRED AREA. CATHETER OCCLUSION AND ENCRUSTATION ARE BOTH LISTED IN THE POTENTIAL COMPLICATIONS SECTION OF THE DFU. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR POLARIS URETERAL STENT WAS USED IN AN UNKNOWN PROCEDURE (PATIENT ID AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STENT PUT IN ON (B)(6) 2011. WHEN ATTEMPTING TO REMOVE THE STENT ON (B)(6) 2011, THE STENT WOULD NOT UNCURL. A WIRE WAS INSERTED TO STRAIGHTEN THE STENT, HOWEVER, IT WAS UNABLE TO PASS DUE TO A STONE. A LASER WAS USED ON THE TISSUE, AND PROLONGED THE SURGERY APPROXIMATELY 20 MINUTES. 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 "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR POLARIS URETERAL STENT WAS USED IN AN UNKNOWN PROCEDURE (PATIENT ID AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STENT PUT IN ON (B)(6), 2011. WHEN ATTEMPTING TO REMOVE THE STENT ON (B)(6), 2011, THE STENT WOULD NOT UNCURL. A WIRE WAS INSERTED TO STRAIGHTEN THE STENT, HOWEVER IT WAS UNABLE TO PASS DUE TO A STONE. A LASER WAS USED ON THE TISSUE, AND PROLONGED THE SURGERY APPROXIMATELY 20 MINUTES. 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 "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR POLARIS URETERAL STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M0061901440 12363917

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention