BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLVE®

    MDR report key: 13005428 · Received December 14, 2021

    Report

    Report Number
    3010665433-2021-00123
    Event Type
    Death
    Date Received
    December 14, 2021
    Date of Event
    October 8, 2021
    Report Date
    December 8, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    UDI-DI
    00884450009482
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT IS NOTED IN SECTION B.5 OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED AND COMMENCED ON INTRAVENOUS ANTIBIOTICS FOR SUSPECTED CELLULITIS TO BILATERAL LEGS WITH REFERRAL FOR INSERTION OF ASCITIC DRAIN (ABDOMINAL CAVITY) TO REDUCE FLUID RETENTION. DURING THE DRAINAGE TUBE PLACEMENT PROCEDURE, AN 8-FRENCH GAUGE PIGTAIL CATHETER WAS SUCCESSFULLY INSERTED AND SECURED TO THE ANTERIOR ABDOMINAL WALL ON THE RIGHT SIDE IN THE LOWER ILIAC FOSSA. THE CATHETER WAS PLACED UNDER ULTRASOUND GUIDANCE IN THE MEDICAL IMAGING (MI) DEPARTMENT PRIOR TO RETURNING TO THE WARD FOR MONITORING FOR A PLANNED DRAINAGE TIME OF SIX HOURS PRIOR TO REMOVAL (SCHEDULED FOR 20:30 HOURS). THE PATIENT WAS RETURNED TO THE WARD FOR OBSERVATION WITHOUT NOTED COMPLICATIONS FOLLOWING THE PROCEDURE. DURING THE DRAINAGE TUBE REMOVAL PROCEDURE, THE MEDICAL STAFF REPORTED THAT THEY WERE FAMILIAR WITH THIS TYPE OF DRAINAGE CATHETER AND HOW TO REMOVE THE DEVICE FROM THE PATIENT. WHEN THE HUB WAS CUT OFF, A LARGE AMOUNT OF FLUID GUSHED OUT WHICH STARTLED THE NURSE, RESULTING IN LOSS OF GRIP ON THE DRAINAGE CATHETER. THE PATIENT INHALED AT THE SAME TIME, AND THE DRAINAGE CATHETER WITHDREW INTO THE PATIENT'S ABDOMEN RESULTING IN THE UNINTENDED RETENTION. THE HUB WAS NOT KEPT FOR EVALUATION. THE PATIENT WAS REVIEWED BY THE MEDICAL/SURGICAL TEAM. THE PATIENT WAS STARTED ON ADDITIONAL INTRAVENOUS ANTIBIOTICS. THE RETAINED CATHETER WAS LOCATED BY CT SCAN IN THE RIGHT HEMIPELVIS IT'S LOCATED BETWEEN THE ABDOMEN AND THE LEGS. THE PATIENT'S HIGH RISK OF COMPLICATIONS FROM SURGERY WERE DISCUSSED, AND A PROPOSAL WAS MADE TO DISCHARGE THE PATIENT WITH ANTIBIOTIC COVER AND RECONSIDER REMOVAL SHOULD THE PATIENT DEVELOP AN INFECTION. THE PATIENT WAS DISCHARGED POST-EVENT ON ORAL ANTIBIOTICS FOR SURGICAL OUTPATIENT FOLLOW UP IN TWO WEEKS. THIRTEEN [13] DAYS LATER THE PATIENT RE-PRESENTED POST-EVENT, EXPERIENCING ABDOMINAL PAIN. THE INITIAL DIAGNOSIS WAS MADE AS PORTAL VEIN THROMBOSIS AND THE PATIENT WAS TRANSFERRED TO A TERTIARY FACILITY WHERE THE PATIENT'S CONDITION DETERIORATED. THE PATIENT'S CAUSE OF DEATH WAS LISTED AS BACTERIAL PERITONITIS WITH ASCITES, SECONDARY DIAGNOSIS IDENTIFIED FOREIGN BODY IN ABDOMEN; DECOMPENSATED END-STAGE LIVER FAILURE; PORTAL VEIN AND SUPERIOR MESENTERIC VEIN THROMBOSIS WITH BOWEL ISCHEMIA AND ACUTE KIDNEY INJURY. UNABLE TO DETERMINE THE ACTUAL LEVEL OF CONTRIBUTION THE RETAINED DRAINAGE CATHETER HAD IN THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER WAS INSERTED IN A (B)(6) YEAR-OLD MALE PATIENT ON (B)(6) 2021, AND WAS TO BE REMOVED AFTER 6 HOURS OF DRAINAGE THE SAME DAY. DURING REMOVAL OF THE CATHETER AN INCIDENT OCCURRED WHEREBY THE TUBING WAS RETAINED IN THE PATIENT'S ABDOMEN. PATIENTS' SITUATION WAS REVIEWED BY SURGEON, BUT UNABLE TO MANUALLY LOCATE AND/OR REMOVE THE FOREIGN BODY TUBING. THE PATIENT WAS ADMINISTERED PROPHYLACTIC IV/PO ANTIBIOTICS. THE PATIENT REQUIRED OTHER INVESTIGATIONS AND WAS CONSIDERED A HIGH RISK FOR COMPLICATIONS IF REQUIRING ANESTHESIA FOR SURGERY. THE DECISION WAS MADE TO DISCHARGE PATIENT HOME ON (B)(6) 2021 WITH FOREIGN BODY STILL WITHIN THE PATIENT AND PO ANTIBIOTICS AND FOLLOW UP APPOINTMENT. THE PATIENT PRESENTED AGAIN ON (B)(6) 2021 TO WITH ABDOMINAL PAIN AND WAS THEN TRANSFERRED FOR FURTHER INVESTIGATION AND MANAGEMENT. THE PATIENT UNDERWENT AN UPPER GI ENDOSCOPY AND GENERAL SURGERY REVIEW, THE PHYSICIAN AGAIN NOTED THAT THE PATIENT WAS NOT A GOOD CANDIDATE FOR SURGICAL INTERVENTIONS. THE PATIENT WAS STARTED ON A HEPARIN INFUSION FOR VENOUS THROMBUS AND PIPERACILLIN FOR INFECTION. PATIENT WAS ADMITTED FOR OBSERVATION, THE PATIENT'S CONDITION DETERIORATED, AND THE PATIENT PASSED AWAY ON THE (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896429 RESOLVE® CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC. 00884450009482 E2164981 00884450009482

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H