BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OQY INTRAUTERINE BALLOON

    MDR report key: 12328341 · Received August 16, 2021

    Report

    Report Number
    1820334-2021-01997
    Event Type
    Injury
    Date Received
    August 16, 2021
    Report Date
    October 18, 2021
    Manufacturer
    COOK INC
    Product Code
    OQY
    PMA / PMN Number
    K170622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY: AS REPORTED IN THE LITERATURE BY KAPOOR ET AL., A COOK BAKRI BALLOON WAS USED TO TREAT A SECONDARY POSTPARTUM HEMORRHAGE, AND THE UTERUS RUPTURED. INVESTIGATION - EVALUATION REVIEWS OF THE INSTRUCTIONS FOR USE AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. NO DEVICE WAS RETURNED FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, REVIEWS OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. NO GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH STATE THAT THE INTENDED USE OF THE DEVICE IS TO PROVIDE TEMPORARY CONTROL OR REDUCTION OF POSTPARTUM BLEEDING WHEN CONSERVATIVE MANAGEMENT IS WARRANTED. THE IFU WARNS THAT THE DEVICE IS INDICATED FOR USE IN THE EVENT OF PRIMARY POSTPARTUM HEMORRHAGE WITHIN TWENTY-FOUR HOURS OF DELIVERY. THE IFU INSTRUCTS THAT PRIOR TO PLACEMENT, THE UTERUS SHOULD BE FREE OF ALL PLACENTAL FRAGMENTS AND THE PATIENT SHOULD BE EVALUATED TO ENSURE THAT THERE ARE NO LACERATIONS OR TRAUMA TO THE GENITAL TRACT AND THAT THE SOURCE OF BLEEDING IS NOT ARTERIAL. THE IFU INSTRUCTS THE USER TO DETERMINE THE UTERINE VOLUME BY DIRECT OR ULTRASOUND EXAMINATION AND TO CONFIRM PLACEMENT WITH ULTRASOUND AFTER INFLATION. THE MAXIMUM INFLATION VOLUME, PER THE IFU, IS 500ML. THE IFU WARNS AGAINST OVER-INFLATION. CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO, ARTERIAL BLEEDING REQUIRING SURGICAL EXPLORATION OR ANGIOGRAPHIC EMBOLIZATION AND CASES INDICATING HYSTERECTOMY. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE OFF-LABEL USE OF THE DEVICE CONTRIBUTED TO THIS ADVERSE EVENT. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER CUSTOMER NAME AND ADDRESS= PHONE: (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE BY KAPOOR ET AL., A COOK BAKRI BALLOON WAS USED TO TREAT A SECONDARY POSTPARTUM HEMORRHAGE AND THE UTERUS RUPTURED. TWO WEEKS AFTER A NORMAL VAGINAL DELIVERY, THE MULTIPAROUS PATIENT UNDERWENT SUCTION EVACUATION OF THE UTERUS USING ULTRASOUND GUIDANCE. THE PATIENT RETURNED TO SURGERY WHEN HEAVY BLEEDING WAS NOTED IN THE RECOVERY ROOM. A LAPAROSCOPY WAS PERFORMED TO RULE OUT UTERINE RUPTURE. REPEAT CURETTAGE WAS PERFORMED; HOWEVER, BLEEDING DID NOT STOP. USING ULTRASOUND GUIDANCE, A COOK BAKRI BALLOON WAS INSERTED AND INFLATED WITH 500 MILLILITERS OF NORMAL SALINE. THE PATIENT APPEARED TO STABILIZE AND WAS TRANSFERRED TO THE WARD. A FEW HOURS AFTER THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND TACHYCARDIC. THE FUNDUS HAD RISEN, BUT THERE WAS NO EXTERNAL BLEEDING. FOUR HUNDRED MILLILITERS OF BLOOD WAS NOTED IN A COLLECTION BAG THE FIRST FOUR HOURS AFTER THE PROCEDURE BUT HAD SUBSIDED. A BEDSIDE ULTRASOUND FOUND LARGE CLOTS IN THE UTERUS ABOVE THE BALLOON. THE PATIENT¿S HEMOGLOBIN WAS 5.3 G/DL, AND SHE WAS DEVELOPING DISSEMINATED INTRAVASCULAR COAGULATION. APPROXIMATELY TWELVE HOURS AFTER PLACEMENT OF THE BAKRI, THE PATIENT WAS TAKEN TO SURGERY FOR A LAPAROTOMY, WHERE THE UTERUS WAS FOUND TO BE PERFORATED AT THE LOWER ANTERIOR SEGMENT. BLEEDING WAS NOTED AT THE UTERINE EDGE, AND 500ML OF BLOOD CLOTS WERE SEEN IN THE FUNDUS, ABOVE THE BALLOON. TISSUES WERE REPORTEDLY FRIABLE DUE TO POSSIBLE INFECTION. A HYSTERECTOMY WAS THEN PERFORMED. TOTAL BLOOD LOSS WAS ESTIMATED TO BE 2.7 LITERS. THE PATIENT RECEIVED FIFTEEN UNITS OF BLOOD AND BLOOD PRODUCTS. DRAINAGE OF A PELVIC COLLECTION WAS PERFORMED SIX DAYS LATER. THE PATIENT MADE A SLOW RECOVERY. THE ARTICLE ALSO REFERENCES THREE ADDITIONAL CASES OF UTERINE PERFORATION AND THE BAKRI BALLOON. THOSE ARTICLES HAVE BEEN PREVIOUSLY REPORTED UNDER REPORT NUMBERS 1820334-2021-01973, 1820334-2021-01974, AND 1820334-2021-01975. REFERENCE FOR ARTICLE: KAPOOR, S., SIVANESAN, K., & VEERASINGHAM, M., 2018. BAKRI BALLOON- A CAUTIONARY TALE. EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY. 221, (203-204). HTTP://DX.DOI.ORG/10.1016/J.E.JOGRB.2017.12.045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220828 OQY INTRAUTERINE BALLOON OQY COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention