BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE STENT

    MDR report key: 6975056 · Received October 24, 2017

    Report

    Report Number
    3005099803-2017-03227
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    August 21, 2016
    Report Date
    September 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K834468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC UPN AND LOT WERE NOT REPORTED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4). REPORT SOURCE: LITERATURE JOURNAL ARTICLE: OSMAN, ET AL. "EXTERNAL STENT VERSUS DOUBLE J DRAINAGE IN PATIENTS WITH RADICAL CYSTECTOMY AND ORTHOTOPIC URINARY DIVERSION: A RANDOMIZED CONTROLLED TRIAL." INTERNATIONAL JOURNAL OF UROLOGY 2016; 23: 861-865. DOI HTTP://DX.DOI.ORG/10.1111/IJU.13173 THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS PERTAINING TO THE USE OF THE PERCUFLEX 6F URETERAL STENT THROUGH THE ARTICLE "EXTERNAL STENT VERSUS DOUBLE J DRAINAGE IN PATIENTS WITH RADICAL CYSTECTOMY AND ORTHOTOPIC URINARY DIVERSION: A RANDOMIZED CONTROLLED TRIAL " WRITTEN BY YASSER OSMAN, ET AL. ACCORDING TO THE LITERATURE, PATIENTS UNDERGOING RADICAL CYSTECTOMY AND ORTHOTOPIC NEOBLADDER WERE RANDOMIZED INTO TWO GROUPS; GROUP I PATIENTS RECEIVED EXTERNAL STENTS, WHEREAS GROUP II RECEIVED PERCUFLEX 6-FR URETERAL STENTS. THE OBJECTIVE OF THE STUDY WAS TO COMPARE TREATMENT-RELATED OUTCOMES OF URETERAL STENTING WITH AN EXTERNAL STENT VERSUS A DOUBLE J STENT. THE STUDY TOOK PLACE FROM SEPTEMBER 2008 AND AUGUST OF 2012. FORTY FIVE PATIENTS RECEIVED PERCUFLEX 6F URETERAL STENTS. THE MEAN AGE OF THESE PATIENTS WAS 55.8 YEARS OF AGE, AND INCLUDED A TOTAL OF 36 MALES AND 9 FEMALES. THE PATIENTS WERE ANALYZED FOR THE PRIMARY OUTCOME AT 90 DAYS AFTER HOSPITAL DISCHARGE. ALL OF THE PATIENTS UNDERWENT RADICAL CYSTECTOMY WITH STANDARD PELVIC LYMPHADENECTOMY FOLLOWED BY ILEAL NEOBLADDER USING THE HAUTMANN TECHNIQUE. URETERAL IMPLANTATION WAS ACCOMPLISHED IN A DIRECT END- TO- SIDE FASHION TO THE CORRESPONDING SHORT CHIMNEYS FROM THE POUCH. THE PATIENTS WERE DISCHARGED ON THE 10TH POSTOPERATIVE DAY. DRAINS WERE REMOVED ON THE 5TH AND 6TH DAY POSTOPERATIVELY AFTER EVALUATING THE NATURE OF THE DRAINED FLUID BY CREATININE ESTIMATION. WHEN URINE WAS DETECTED IN THE DRAINS, THE PATIENTS WERE COUNTED AS URINARY LEAK CASES, AND REMOVAL OF THE DRAINS WAS POSTPONED. PATIENTS WERE DISCHARGED WITH A POUCHOSTOMY TUBE AND URETHRAL CATHETER WHICH WERE REMOVED ON THE 21ST POSTOPERATIVE DAY ON AN OUTPATIENT BASIS. AFTER TWO WEEKS, THE PATIENTS WERE RE-ADMITTED FOR CYSTOSCOPIC REMOVAL OF THE PERCUFLEX STENTS. IN THE PERCUFLEX 6F GROUP, IT WAS REPORTED THAT URINARY LEAKAGE OCCURRED IN 2 PATIENTS. LEAKAGE TIME WAS 3 DAYS AND 20 DAYS. THE ARTICLE REPORTED THAT MOST LEAKS WERE SELF-LIMITED AND WERE OF SHORT DURATION. THEY WERE MANAGED BY PROLONGATION OF DRAINING CATHETERS. ONE PATIENT REQUIRED PROXIMAL URINARY DIVERSION WITH BILATERAL NEPHROSTOMY TUBE FIXATION. THREE PATIENTS DEVELOPED FEBRILE URINARY TRACT INFECTIONS (2-10 DAYS DURATION) AMONG 23 PATIENTS WITH POSITIVE URINE CULTURE. URINE CULTURE WAS COLLECTED ON THE FIRST AND EIGHTH DAYS AS WELL AS THE DAY OF DISCHARGE. THE PATIENTS' INFECTIONS WERE WELL CONTROLLED BY CULTURE BASED ANTIBIOTICS. EARLY MILD BILATERAL HYDRONEPHROSIS WAS OBSERVED IN THREE PATIENTS FOUR CASES DEVELOPED WOUND INFECTION; TWO OF THEM REQUIRED SECONDARY SUTURES. ONE PATIENT REQUIRED PROXIMAL URINARY DIVERSION WITH BILATERAL NEPHROSTOMY TUBE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753574 DRAINAGE STENT CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention