BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 1994428 · Received February 17, 2011

    Report

    Report Number
    3005099803-2011-00355
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE INDICATED THE TEAR IN THE STENT IS CONSISTENT WITH THOSE CAUSED BY THE SUTURE. THE PROXIMAL END OF THE STENT WAS TORN; HOWEVER, IT DOES NOT APPEAR THAT ANY OF THE STENT DETACHED. THE TEAR IS CONSISTENT WITH THOSE CAUSED BY THE SUTURE. THE SUTURE WAS NOT PRESENT WITH THE RETURN. PER THE EVENT INFORMATION, THE DEFECT WAS IDENTIFIED DURING INTRODUCTION OF THE DEVICE FOR THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.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 HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER WAS USED IN A "PLACEMENT OF URETERAL STENT" PROCEDURE (PATIENT ID, AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN TRIED TO PLACE THE STENT, THE PIGTAIL OF THE URINARY BLADDER SIDE WAS TORN. THE PIGTAIL WAS NOT DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER WAS USED IN A "PLACEMENT OF URETERAL STENT" PROCEDURE (PATIENT ID, AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN TRIED TO PLACE THE STENT, THE PIGTAIL OF THE URINARY BLADDER SIDE WAS TORN. THE PIGTAIL WAS NOT DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER. 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 "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M0061752540

    Patients

    Seq Age Sex Outcome Treatment
    1