BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS¿ ULTRA

    MDR report key: 2860920 · Received December 6, 2012

    Report

    Report Number
    3005099803-2012-05916
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED POLARIS ULTRA URETERAL STENT REVEALED THAT THE SUTURE HOLE WAS RIPPED ALL THE WAY TO THE END OF THE DEVICE. THE TEAR IS CONSISTENT WITH ONE CAUSED BY THE SUTURE WHEN IT IS BEING PULLED. ADDITIONALLY, THE SUTURE WAS NOT RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT THE EVENT OF STENT SEPARATION DUE TO SUTURE REMOVAL DURING PREPARATION, IS NOT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF STENT CRACKED. ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION TO PLACE A POLARIS ULTRA URETERAL STENT, WHEN THE DEVICE WAS UNPACKED, THE LOOP OF THE STENT WAS NOTICED TO BE "CRACKED." 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 "GOOD" REPORTEDLY, NO FURTHER INFORMATION IS AVAILABLE. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION TO PLACE A POLARIS ULTRA URETERAL STENT, WHEN THE DEVICE WAS UNPACKED, THE LOOP OF THE STENT WAS NOTICED TO BE "CRACKED." 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 "GOOD." REPORTEDLY, NO FURTHER INFORMATION IS AVAILABLE. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS¿ ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M006192132090

    Patients

    Seq Age Sex Outcome Treatment
    1