BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG

    MDR report key: 18134912 · Received November 14, 2023

    Report

    Report Number
    1835959-2023-00002
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 14, 2023
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    UDI-DI
    10827002236537
    PMA / PMN Number
    K082682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION INVESTIGATION INTO THIS FEEDBACK INCLUDED 1) A REVIEW OF THE FEEDBACK DETAILS, 2) A REVIEW OF THE DEVICE LOT HISTORY RECORD, 3) A REVIEW OF THE CBI COMPLAINT DATABASE, 4) CBI ENGINEERING EVALUATION OF EXPLANTED FLANGE, AND 5) A REVIEW OF THE BIODESIGN ENTEROCUTANEOUS FISTULA PLUG IFU FP0069-01J. SUMMARY OF INVESTIGATION FINDINGS A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE NONCONFORMANCES WOULD NOT HAVE CONTRIBUTED TO THE DEVICE. THE LOT PRODUCED A TOTAL OF 4 DEVICES. PER THE LOT HISTORY RECORD, ALL DEVICES RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS. THE A LOT FOR THE FLANGE HAD 2023-NCMR-00039 ASSOCIATED WITH IT. PER THE HRA, THE FLANGES CONFORMED TO THE EXISTING SPECIFICATIONS AND WERE DEEMED SAFE FOR CONTINUED INCORPORATION INTO THE EFP DEVICE. A REVIEW OF THE CBI COMPLAINT SYSTEM DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. THE ROOT CAUSE OF THE PATIENT'S PAIN WAS DUE TO THE RETAINED FLANGE. THE ROOT CAUSE OF THE FLANGE NOT PASSING IS INCONCLUSIVE. MANY FACTORS COULD CONTRIBUTE TO THIS OCCURRENCE INCLUDING, BUT NOT LIMITED TO SIZE OF PLUG CHOSEN FOR IMPLANT AND LOCATION OF THE FLANGE. THE SEPARATION OF THE SILICONE FROM THE NITINOL RING ON THE FLANGE IS NOT BELIEVED TO HAVE LED TO THE PATIENT'S INABILITY TO PASS THE FLANGE. THE EXPLANTED FLANGE WAS RETURNED TO CBI AND WAS EVALUATED BY ENGINEERING. THE FOLLOWING FINDINGS WERE PROVIDED IN A MEMO (IN THE ATTACHED FILES) FROM CBI ENGINEERING: THE FLANGE OF A BIODESIGN® ENTEROCUTANEOUS FISTULA PLUG (ECPD-0.7-TAG) WAS RETURNED TO COOK BIOTECH INC. AFTER FEEDBACK FROM PR412467 REPORTED THAT IT WAS SURGICALLY REMOVED FROM A PATIENT DUE TO PAIN NEAR THE RECTUM WHEN PRESSURE WAS APPLIED. UPON REMOVAL, THE PHYSICIAN NOTED THAT PART OF THE OCTAGONAL POLYURETHANE DISK HAD SEPARATED FROM THE EMBEDDED NITINOL RING. ALTHOUGH THE FLANGE DID NOT PASS ON ITS OWN, THERE WAS NO INJURY TO THE PATIENT, AND THE FISTULA DID CLOSE AND HEAL COMPLETELY. ONCE THE FLANGE ARRIVED AT CBI, IT WAS VISUALLY INSPECTED AND IMAGED USING A TRADITIONAL CAMERA AS WELL AS A HANDHELD MICROSCOPE. THE FLANGE DIMENSION MEASURED ABOUT 24MM, WHICH IS WITHIN THE DIMENSIONAL TOLERANCE OUTLINED IN THE 20MM POLYURETHANE FLANGE SPECIFICATION, SC.11140. THE FLANGE WAS OFF-WHITE AND BROWN IN COLOR, STAINED BY THE ENTERIC CONTENTS IT WAS EXPOSED TO WHILE IMPLANTED. THE PIN OF THE FLANGE ASSEMBLY WAS RETURNED AS WELL, SECURELY SEATED THROUGH THE CENTER HOLE OF THE FLANGE. THE EMBEDDED RING WAS SEPARATED FROM THE POLYURETHANE DISK COMPLETELY ON TWO OF THE OCTAGONAL SIDES, AND PARTIAL TEARS WERE VISIBLE ON THE TWO SIDES FLANKING THE SEPARATION. THE POLYURETHANE UNDERSIDE OF THE FLANGE WAS FLAT, SHOWING NO OBVIOUS BREACHES IN THE MATERIAL. THE NITINOL FRAME PROTRUDED FROM THE TOP SIDE OF THE FLANGE, WHICH WAS COVERED BY POLYURETHANE. THE SITE OF SEPARATION COULD ONLY BE VIEWED FROM THE TOP SIDE, AS THE POLYURETHANE COATING HAD SPLIT, EXPOSING THE NITINOL RING BELOW. WHEN THE DEVICE IS IMPLANTED, THE UNDERSIDE FACES THE FISTULA TRACT WHILE THE TOP SIDE IS EXPOSED TO THE INNER BOWEL, OR RECTUM IN THIS CASE. THEREFORE, THE NITINOL RING FACES THE INSIDE OF THE BOWEL WHEN SECURED PROPERLY. POTENTIAL POINTS OF USE WHEN THE SEPARATION OCCURRED: STEPS 29-30 OF THE IFU: WRAPPING AND INSERTION OF FLANGE INTO THE TRANSFER TUBE. STEP 33 OF THE IFU: ADVANCEMENT OF THE FLANGE OUT OF THE TRANSFER TUBE. STEP 39 OF THE IFU: SEATING OF THE FLANGE AGAINST THE BOWEL WALL. ADDED PRESSURE DURING SPHINCTER CONTRACTION WHILE STRUGGLING TO PASS THE FLANGE (B)(4) MANUAL MANIPULATION OF THE FLANGE BY THE PHYSICIAN DURING SURGICAL REMOVAL FROM THE PATIENT A REVIEW OF MARKET FEEDBACK INVOLVING THE BIODESIGN® EFP SHOWED NO OCCURRENCES INVOLVING THE SEPARATION OF THE POLYURETHANE DISK FROM THE NITINOL FRAME. POST-MARKET FEEDBACK FROM PRODUCT LAUNCH TO JANUARY 2023 WAS COLLECTED, SORTED, AND REVIEWED IN RESIDUAL RISK MEMOS (D00506774 REV. 6, REV. 7) AS A PART OF RMF 41 UPDATES. ALL MARKET FEEDBACK SINCE JAN 2023 WAS REVIEWED THROUGH POST-MARKET SURVEILLANCE COMMUNICATIONS. SINCE THERE ARE NO OTHER EXISTING OBSERVATIONS OF FLANGE MATERIAL SEPARATION IN THE DEVICE¿S HISTORY AND THE IMPLANTATION PROCEDURE STEPS HAVE NOT CHANGED SIGNIFICANTLY, THE SOURCE OF THIS FINDING MAY BE LOT-SPECIFIC. A LOT SEARCH OF THE RETURNED DEVICE REVEALED THAT IT ORIGINATED FROM A LOT INVESTIGATED IN 2023 (B)(6). IN THAT REPORT, MICROSCOPIC BUBBLES OR AIR POCKETS WERE DISCOVERED IN THE POLYURETHANE MATERIAL WHICH MAY HAVE RESULTED IN AIR-EXPOSED NITINOL. ALTHOUGH THE FLANGE SPECIFICATION LISTS ¿NO VISIBLE EXPOSURE OF THE NITINOL FRAME TO AIR¿ AS A VISUAL INSPECTION REQUIREMENT, THE EXPOSED AREAS OF THE NITINOL RING FOUND IN 2023-NCMR-00039 CANNOT BE DETECTED WITHOUT A MICROSCOPE, AND CURRENT INSPECTIONS ARE ACCOMPLISHED WITHOUT MAGNIFICATION. SINCE THESE UNCOATED SECTIONS OF NITINOL WERE DISCOVERED IN OTHER EFP FLANGES FROM THE SAME LOT, IT IS POSSIBLE THIS DEFECT ALSO OCCURRED IN THE FLANGE ASSOCIATED WITH (B)(4). A HEALTH RISK ASSESSMENT, WAS CONDUCTED TO OUTLINE POTENTIAL PATIENT RISKS, FAILURE MODES, AND EFFECTS OF NITINOL EXPOSURE. THESE INCLUDED NITINOL FRAME INCORPORATION INTO AND/OR IRRITATION OF THE BOWEL, TEARING OR FRACTURING OF THE FLANGE MATERIAL, FLANGE RETENTION IN THE BOWEL, AND FLANGE COLLAPSE UNDER TENSILE LOAD PLACED ON THE PLUG. PER THE IFU, IF THE FLANGE IS RETAINED IN THE PATIENT BEYOND AN EIGHT WEEK PERIOD, THE PATIENT SHOULD BE MONITORED FOR BOWEL OBSTRUCTION, EROSION, PERFORATION OR FLANGE MIGRATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A BIODESIGN ENTEROCUTANEOUS FISTULA PLUG WAS PLACED FOR REPAIR OF AN ENTEROCUTANEOUS FISTULA. THE PATIENT HAD THE ANAL CUTANEOUS FISTULA FOR OVER A YEAR. THE FISTULA EXITED OUT OF THE GLUTEUS. THERE WAS NO DISTAL OBSTRUCTION. THE PATIENT HAD NO HISTORY OF RECEIVING RADIATION. THE FISTULA DRAINED LESS THAN 20 ML/DAY. THE FISTULA TRACT WAS 11 CM IN LENGTH AND AROUND 2 MM IN DIAMETER. THERE WERE NO 4 MM PLUG SETS AVAILABLE AT THE IMPLANTING FACILITY. THE PHYSICIAN MADE THE DECISION TO IMPLANT A 7 MM PLUG. THE PLUG WAS SUCCESSFUL AT HEALING THE FISTULA HOWEVER, THE FLANGE WOULD NOT PASS ON ITS OWN WHICH CAUSED THE PATIENT TO EXPERIENCE PAIN. THE PAIN WAS NEAR THE PATIENT'S RECTUM AND OCCURRED WHEN PRESSURE WAS APPLIED. ON (B)(6) 2023, THE PHYSICIAN ATTEMPTED TO LAPAROSCOPICALLY REMOVE THE FLANGE. DUE TO THE LOCATION OF THE FLANGE,NEAR THE RECTUM RIGHT NEXT TO OR POSSIBLY ON THE SPHINCTER, THE FLANGE WAS REMOVED MANUALLY. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL COMPLICATIONS OR HARM. UPON EXAMINATION OF THE EXPLANTED FLANGE, THE PHYSICIAN NOTICES THAT THE SILICONE HAD PARTIALLY SEPARATED FROM THE NITINOL RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876411 BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG ENTEROCUTANEOUS FISTULA PLUG FTM COOK BIOTECH LB1501892 10827002236537

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention