BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL INDWELLING CATHETER/STENT

    MDR report key: 2163058 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02423
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING THE FOLLOW-UP APPOINTMENT TO ASSESS THE PATIENT'S STENT-RELATED INJURIES, THE PATIENT PRESENTED WITH HYDRONEPHROSIS DUE TO THE ENCRUSTATION OF THE STENT. IT WAS ALSO DETERMINED THAT THE PATIENT HAD SUFFERED INJURY OF THE PELVIC URETERIC JUNCTION DURING PREVIOUS ATTEMPTS TO UNTIE THE KNOTTED AND ENCRUSTED STENT. THE STENT HAD FINALLY BEEN REMOVED USING LASER AND LITHOCLAST. THE PATIENT WAS GIVEN PAIN THERAPY AS WELL AS AN UNKNOWN PRESCRIPTION ANTIBIOTIC, AND IS REPORTEDLY STABLE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6) 2011 A CONTOUR VL URETERAL STENT WAS PLACED DURING A CYSTOSCOPY PYELOGRAM FLEXIBLE URETERORENOSCOPY PROCEDURE. THE PATIENT RETURNED ON (B)(6) 2011 FOR THE STENT REMOVAL PROCEDURE. PRIOR TO THE PROCEDURE, AN X-RAY WAS TAKEN TO VIEW THE STENT POSITION, AND THE PHYSICIAN NOTED THAT SOMETHING LOOKED STRANGE IN THE KIDNEY. WHILE PULLING ON THE STENT IN AN ATTEMPT TO REMOVE IT DURING CYSTOSCOPY, THE PHYSICIAN NOTICED RESISTANCE. THE STENT WAS DETERMINED BY FLEXIBLE URETERORENOSCOPY TO BE ENCRUSTED AND TIGHTLY KNOTTED. VARIOUS INSTRUMENTS WERE USED TO TRY AND REMOVE THE STENT, AND AFTER A PROLONGED PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED WITH AN UNKNOWN DEVICE. REPORTEDLY, THE OCCLUDED STENT HAD CAUSED THE PATIENT TO EXPERIENCE DIFFICULTY URINATING WHILE THE STENT WAS IN PLACE. DUE TO THE ATTEMPTS TO DISLODGE THE STENT, THE URETER WAS PERFORATED ONCE, AND DAMAGED AROUND THE WHOLE PARAMETER OF THE STENT KNOT. A NEW STENT WAS PLACED TO PREVENT PELVIURETERIC JUNCTION OBSTRUCTION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE," BUT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR (B)(6) FOR OBSERVATION BECAUSE OF THE PERFORATED AND DAMAGED URETER. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT TO OCCUR (B)(6) LATER, IN ORDER TO "ASSESS THE EXTENT OF THE DAMAGE." ATTEMPTS TO OBTAIN ADDITIONAL PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6) 2011 A CONTOUR VL URETERAL STENT WAS PLACED DURING A CYSTOSCOPY PIELOGRAM FLEXIBLE URETERORENOSCOPY PROCEDURE. THE PATIENT RETURNED ON (B)(6) 2011 FOR THE STENT REMOVAL PROCEDURE. PRIOR TO THE PROCEDURE, AN X-RAY WAS TAKEN TO VIEW THE STENT POSITION, AND THE PHYSICIAN NOTED THAT SOMETHING LOOKED STRANGE IN THE KIDNEY. WHILE PULLING ON THE STENT IN AN ATTEMPT TO REMOVE IT DURING CYSTOSCOPY, THE PHYSICIAN NOTICED RESISTANCE. THE STENT WAS DETERMINED BY FLEXIBLE URETERORENOSCOPY TO BE ENCRUSTED AND TIGHTLY KNOTTED. VARIOUS INSTRUMENTS WERE USED TO TRY AND REMOVE THE STENT, AND AFTER A PROLONGED PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED WITH AN UNKNOWN DEVICE. REPORTEDLY, THE OCCLUDED STENT HAD CAUSED THE PATIENT TO EXPERIENCE DIFFICULTY URINATING WHILE THE STENT WAS IN PLACE. DUE TO THE ATTEMPTS TO DISLODGE THE STENT, THE URETER WAS PERFORATED ONCE, AND DAMAGED AROUND THE WHOLE PARAMETER OF THE STENT KNOT. A NEW STENT WAS PLACED TO PREVENT PELVIURETERIC JUNCTION OBSTRUCTION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE," BUT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FIVE DAYS FOR OBSERVATION BECAUSE OF THE PERFORATED AND DAMAGED URETER. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT TO OCCUR TWO WEEKS LATER, IN ORDER TO "ASSESS THE EXTENT OF THE DAMAGE." ATTEMPTS TO OBTAIN ADDITIONAL PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL INDWELLING CATHETER/STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA M0061801560 14164340

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization