BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIODESIGN SURGISIS ENTERCUTANEOUS FISTULA PLUG

    MDR report key: 3057409 · Received April 10, 2013

    Report

    Report Number
    1835959-2013-00032
    Event Type
    Other
    Date Received
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K082682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS REPORT INCLUDED A REVIEW OF THE FEEDBACK DETAILS, COMMUNICATION WITH THE ASSOCIATED COOK SALES REP AND THE CLINICIAN TO VERIFY/CLARIFY THE DETAILS, A REVIEW OF THE CBI COMPLAINT SYSTEM, A REVIEW OF THE DEVICE HISTORY RECORDS WHICH INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS, A REVIEW OF THE BIODESIGN ENTEROCUTANEOUS FISTULA PLUG IFU FP0085-01A, A REVIEW OF THE BIODESIGN ENTEROCUTANEOUS FISTULA PLUG PATIENT GUIDE: POST PROCEDURE CARE FP0069-02B, AND REVIEW OF THE COMPLAINT BY THE INCIDENT INVESTIGATION COMMITTEE. THE ROOT CAUSE OF THE MOLNAR DISC MIGRATION INWARD INTO THE FISTULA TRACT IS BELIEVED TO BE THE AMOUNT OF TENSION PLACED ON THE DEVICE WHEN THE PATIENT'S LARGE BODY HABITUS SHIFTED POSITIONS. THE CLINICIAN EXPLAINED THAT THE PATIENT'S ABDOMINAL WALL EXERTS SO MUCH EXCESS DOWNWARD PRESSURE, WHEN SHE IS UPRIGHT AND THE ABDOMINAL PANNUS HANGS, THAT THE TENSION BETWEEN THE INTERNAL BOWEL FLANGE AND THE EXTERNAL MOLNAR DISC CAUSED THE MOLNAR DISC TO MIGRATE INTO THE FISTULA TRACT. THE BIODESIGN ENTEROCUTANEOUS FISTULA PLUG IFU FP0085-01A POTENTIAL COMPLICATIONS INCLUDE "...MIGRATION."

    Description of Event or Problem · 1

    THE PATIENT HAD AN ENTEROCUTANEOUS FISTULA CAUSED BY DIVERTICULITIS. THE FISTULA HAD BEEN PRESENT FOR THREE YEARS. THE FISTULA TRACT WAS 6-8 CM LONG. PRIOR TO PLACEMENT OF THE EFP, THE FISTULA DRAINED APPROX. 25 ML/DAY. MOST OF THE TRACT WAS VERY SMALL IN CALIBER. MIDWAY ALONG THE TRACT WAS A SMALL POUCH THAT HAD BEEN AN ABSCESS IN THE PAST. THE INTERNAL FISTULA OPENING WAS LOCATED IN THE SIGMOID COLON AND HAD A DIAMETER OF 1.02.0 MM. AT THE TIME OF EFP PLACEMENT, THE MOLNAR DISC WAS NOT SUTURED TO THE SKIN. AT AN UNSPECIFIED POINT OF TIME AFTER EFP PLACEMENT, THE MOLNAR DISC RETRACTED INTO THE FISTULA TRACT. THIS WAS VERIFIED VIA CT SCAN. THE CLINICIAN WAS ABLE TO RETRIEVE THE MOLNAR DISC. THE FISTULA PLUG WAS STILL INTACT AND THE CLINICIAN SUTURED THE MOLNAR DISC TO THE SKIN. AFTER RETRIEVAL OF THE MOLNAR DISC AND SUTURING TO THE SKIN, THE PATIENT WAS SENT HOME. AS OF (B)(6) 2013, THE EFP WAS STILL IN PLACE IN THE PATIENT AND THE PATIENT HAD NOT HAD ANY SIGNIFICANT CHANGES IN HER FISTULA DRAINAGE. THE PATIENT WILL CONTINUE TO BE EVALUATED BY THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148190 BIODESIGN SURGISIS ENTERCUTANEOUS FISTULA PLUG ENTEROCUTANEOUS FISTULA PLUG FTL COOK BIOTECH, INC. LB608876

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention