BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA¿ APDL

    MDR report key: 5659761 · Received May 17, 2016

    Report

    Report Number
    2134265-2016-03919
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    September 29, 2015
    Report Date
    April 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: PATIENT IDENTIFIER, DATE OF BIRTH, WEIGHT, WEIGHT (UNIT), DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY, NAME PREFIX, FIRST NAME, LAST NAME, COMPLAINANT NAME, COMPLAINANT ADDRESS, COMPLAINANT CITY, COMPLAINANT STATE / PROV, COMPLAINANT POSTAL CODE, INITIAL REPORTER PHONE, OCCUPATION (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH MW 5060889 THAT THE SUTURE WAS LEFT INSIDE THE PATIENT. A FLEXIMA DRAIN WAS PLACED INTO PATIENT WITH INTRA-ABDOMINAL FLUID COLLECTION ON 2015 BY INTERVENTIONAL RADIOLOGY. THE FLEXIMA DRAIN WAS REMOVED ON 2015 BUT UNKNOWN TO THE CLINICIANS TAKING CARE OF THE PATIENT, PART OF THE DRAIN (COMPRISED OF BLACK SUTURE) BROKE OFF AND WAS RETAINED WITHIN THE ABSCESS. THIS RETAINED SUTURE SERVED AS A FOREIGN BODY AND PREVENTED SUCCESSFUL TREATMENT OF THE ABSCESS. THE ABSCESS WAS RECALCITRANT TO TREATMENT FOR 6 MONTHS. THE PATIENT UNDERWENT OPERATION FOR TREATMENT OF THE ABSCESS ON 2015 WHEN THE RETAINED SUTURE, WHICH HAD BEEN BROKEN OFF FROM THE FLEXIMA DRAIN PLACED ON 2015 WAS REMOVED SURGICALLY. DURING THIS 2015 OPERATION, THEY DETERMINED THAT THE SUTURE MATERIAL AT THE ROOT OF THE ABSCESS WAS IDENTIFIED AS THE BRAIDED SUTURE MATERIAL FROM THE FLEXIMA CATHETER USED TO DRAIN THE FLUID COLLECTION AND WAS A RETAINED FOREIGN BODY THAT CAUSE THE CONTINUATION OF THE ABSCESS AND COLON PERFORATION. THE RETAINED SUTURE MATERIAL IS A DIRECT RESULT OF A MFG DEFECT THAT ALLOWED THE SUTURE TO BREAK OFF IN THE PATIENT. SUBSEQUENTLY AS A RESULT OF THIS DEFECT IN MFG AND BREAKING OFF OF THE SUTURE MATERIAL IN THE PATIENT ,SHE HAS REQUIRED MULTIPLE SURGICAL INTERVENTION TO DRAIN THE ABSCESS, REPAIR THE COLON, AND TREAT COMPLICATIONS THAT ARE A DIRECT RESULT OF THE MFG DEFECT. THE PATIENT HAS NOT YET RECOVERED FROM THE INJURY AND WILL REQUIRE FURTHER OPERATIVE INTERVENTIONS TO REPAIR THE ORIGINAL INJURY. ON COLORRHAPHY OF SMALL SPLENIC FLEXURE PERFORATION USING 3-0 VICRYL, DIVERTING LOOP ILEOSTOMY, AND PRIMARY CLOSURE WITH RETENTION SUTURES WITH DRAIN IN LUQ. PATIENT ADMITTED TO UNIT WITH ABD SEPSIS AND SUPPORTIVE CARE FOR 2 DAYS EVENTUALLY IMPROVING AND TRANSFERRING TO THE FLOOR. ON 2015, PATIENT EVENTUALLY DISCHARGED ON 2015 TOLERATING REGULAR DIET, PO MEDS, PICC LINE FOR 4 WEEKS IV ABX PER ID RECS. (VANC, MEROPENEM, DIFLUCAN). PATIENT HAS REQUIRED IR DRAINAGE OF IAA ABOVE THE LIVER ON AND THORACENTESIS ON FOR NON INFECTIOUS PLEURAL EFFUSION, BOTH AS AN OUTPATIENT PROCEDURE. ON 2015, PATIENT WAS ADMITTED FOR ENDOSCOPIC CLOSURE OF COLOCUTANEOUS FISTULA. ON 2016 SEEN IN CLINIC. FISTULA HEALED. WILL WAIT UNTIL 2016 TO CLOSE ILEOSTOMY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD HER SPLEEN RUPTURE AND UNDERWENT AN EMERGENCY SPLEEN/GALL BLADDER REMOVAL OPERATION. EIGHT (8) WEEKS POST THE INDEX PROCEDURE THE PATIENT WAS RELEASED FROM THE HOSPITAL AND SENT HOME. TEN (10) WEEKS AFTER THE SPLEEN REMOVAL SURGERY, THE PATIENT¿S HEALTHCARE PROVIDERS BEGAN TO REMOVE THE CATHETER, PULLING SOME OF THE TUBE OUT OF THE BODY AND CUTTING THE VISIBLE TUBING. THE PATIENT WENT BACK TO THE HOSPITAL SEVERAL TIMES OVER THE COURSE OF THREE TO FOUR WEEKS TO HAVE HER HEALTHCARE PROVIDERS SLOWLY REMOVE THE CATHETER FROM HER BODY. THE PATIENT WAS CONSTANTLY SICK DURING THE MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT CONSTANTLY HAD URINARY TRACT INFECTIONS, NAUSEA, FEVER, FLUID IN HER LUNGS, AND LOST A STAGGERING AMOUNT OF WEIGHT. SHE WAS MALNOURISHED, WEAK, AND CLOSE TO DEATH. THE PATIENT UNDERWENT EXPLORATORY SURGERY AND THE PHYSICIAN FOUND THE SUTURES FROM THE CATHETER INSIDE THE PATIENT¿S BODY DURING EXPLORATORY LAPAROTOMY, INCISION AND DRAINAGE OF ABDOMINAL ABSCESS, AND REMOVAL OF FOREIGN BODY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ANOTHER MANUFACTURER'S DRAINAGE CATHETER WAS PLACED TO DRAIN THE ABSCESS LOCATED IN THE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316512 FLEXIMA¿ APDL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001271320

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R