BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS¿ ULTRA

    MDR report key: 2760745 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04210
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    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. ANALYSIS OF THE RETURNED POLARIS ULTRA URETERAL STENT REVEALED THAT THE DEVICE WAS TORN AT THE SUTURE HOLE, AND RIPPED FROM THAT HOLE TO THE END OF THE STENT. MOST LIKELY, THE PROBABLE CAUSE FOR THE FAILURE IS RELATED TO HANDLING FACTORS, AS THE UNIT PRESENTED MARKS ON THE BLADDER PIG TAIL SECTION, CONSISTENT WITH MARKS CAUSED BY THE SUTURE WHEN IT IS BEING PULLED. IT SHOULD BE NOTED THAT THE EVENT OF STENT TEAR DUE TO SUTURE REMOVAL DURING PREPARATION, IS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION TO PLACE A POLARIS ULTRA URETERAL STENT A TEAR WAS NOTICED ON ONE OF THE LOOPS. NO FURTHER INFORMATION IS AVAILABLE. THE DETAILS OF THE PROCEDURE ARE UNKNOWN; HOWEVER, THERE WERE NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY 'OK.'

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION TO PLACE A POLARIS ULTRA URETERAL STENT A TEAR WAS NOTICED ON ONE OF THE LOOPS. NO FURTHER INFORMATION IS AVAILABLE. THE DETAILS OF THE PROCEDURE ARE UNKNOWN; HOWEVER, THERE WERE NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS¿ ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061921320 15208565

    Patients

    Seq Age Sex Outcome Treatment
    1