BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7517763 · Received May 16, 2018

    Report

    Report Number
    1820334-2018-01476
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    May 4, 2018
    Report Date
    July 26, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS PERFORMED. THE INVESTIGATION ALSO INCLUDED REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED AND IT WAS NOTED THE BALLOON HAS A PIN HOLE LEAK IN THE BALLOON MATERIAL. A VISUAL EXAMINATION NOTED THERE ARE GRASPER MARKS ON THE BALLOON MATERIAL NEAR THE PIN HOLE LEAK. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8278915. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THIS DEVICE IS 100% INSPECTED VISUALLY FOR SURFACE IMPERFECTIONS AND FUNCTIONALLY TESTED FOR LEAKS, INFLATION, AND DEFLATION. INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS. WARNINGS: CLINICAL DATA TO SUPPORT THE SAFETY AND EFFECTIVENESS OF THE BAKRI POSTPARTUM BALLOON IN THE SETTING OF UTERINE ATONY ARE LIMITED. PATIENTS IN WHOM THIS DEVICE IS BEING USED SHOULD BE CLOSELY MONITORED FOR SIGNS OF WORSENING BLEEDING AND/OR DISSEMINATED INTRAVASCULAR COAGULATION (DIC). IN SUCH CASES, EMERGENCY INTERVENTION PER HOSPITAL PROTOCOL SHOULD BE FOLLOWED. PRECAUTIONS: AVOID EXCESSIVE FORCE WHEN INSERTING THE BALLOON INTO THE UTERUS. HOW SUPPLIED: AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. ANY DAMAGE TO THE BALLOON PRIOR TO INFLATION CAN CAUSE THE BALLOON TO LEAK WHEN INFLATED. THE CAUSE OF THIS ISSUE IS TRACED TO USER FAILURE TO FOLLOW INSTRUCTIONS. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    IT WAS REPORTED THAT AFTER A CESAREAN SECTION, THE PATIENT HAD SUFFERED A POSTPARTUM HEMORRHAGE DUE T OUTERINE ATONY. THE PATIENT WAS GIVEN MASSAGING OF THE UTERUS TO HEMOSTASIS BUT FAILED. THE AMOUNT OF BLEEDING REACHED 1000 ML BEFORE THE BAKRI TAMPONADE BALLOON CATHETER WAS PLACED. THE BALLOON WAS USED TO STOP THE BLEEDING. THE PHYSICIAN PLACED THE BALLOON INTO THE UTERINE CAVITY THROUGH THE INCISIONS, FILLED IT WITH 20 ML OF WATER AND FOUND THE BALLOON WAS LEAKING. THE PHYSICIAN REMOVED THE BALLOON AND FOUND A PIN HOLE IN THE BALLOON. AT LAST, THE PHYSICIAN USED GAUZE PACKING TO STOP THE BLEEDING SUCCESSFULLY. THE AMOUNT OF BLEEDING REACHED 400 ML DURING THE PROCEDURE. PATIENT OUTCOME WAS LISTED AS STABLE AND INFANT CONDITION WAS GOOD.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K170622. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A CESAREAN SECTION, THE PATIENT HAD SUFFERED A POSTPARTUM HAEMORRHAGE DUE TO UTERINE ATONY. THE PATIENT WAS GIVEN MASSAGING OF THE UTERUS TO HEMOSTASIS BUT FAILED. THE AMOUNT OF BLEEDING REACHED 1000 ML BEFORE THE BAKRI TAMPONADE BALLOON CATHETER WAS PLACED. THE BALLOON WAS USED TO STOP THE BLEEDING. THE PHYSICIAN PLACED THE BALLOON INTO THE UTERINE CAVITY THROUGH THE INCISIONS, FILLED IT WITH 20 ML OF WATER AND FOUND THE BALLON WAS LEAKING. THE PHYSICIAN REMOVED THE BALLOON AND FOUND A PIN HOLE IN THE BALLOON. AT LAST, THE PHYSICIAN USED GAUZE PACKING TO STOP THE BLEEDING SUCCESSFULLY.THE AMOUNT OF BLEEDING REACHED 400 ML DURING THE PROCEDURE. PATIENT OUTCOME WAS LISTED AS STABLE AND INFANT CONDITION WAS GOOD.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED BLOOD PRODUCTS DUE TO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362930 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8278915 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention