BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8915701 · Received August 21, 2019

    Report

    Report Number
    1820334-2019-02056
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    October 7, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. REVIEWS OF THE INSTRUCTIONS FOR USE AND QUALITY CONTROL DATA WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL INVESTIGATION COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE INSTRUCTIONS FOR USE (IFU) INCLUDED WITH THIS DEVICE PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: THIS DEVICE INTENDED AS A TEMPORARY MEANS OF ESTABLISHING HEMOSTASIS IN CASES INDICATING CONSERVATIVE MANAGEMENT OF POSTPARTUM UTERINE BLEEDING. 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. THERE ARE NO CLINICAL DATA TO SUPPORT USE OF THIS DEVICE IN THE SETTING OF DIC. PATIENT MONITORING IS AN INTEGRAL PART OF MANAGING POSTPARTUM HEMORRHAGE. SIGNS OF DETERIORATED OR NON-IMPROVING CONDITION SHOULD LEAD TO A MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF PATIENT UTERINE BLEEDING. INSTRUCTIONS FOR USE IMPORTANT: PRIOR TO TRANSVAGINAL OR TRANSABDOMINAL PLACEMENT OF THE BAKRI POSTPARTUM BALLOON, 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 THE BLEEDING IS NOT ARTERIAL. TRANSABDOMINAL PLACEMENT, POST-CESAREAN SECTION NOTE: ENSURE THAT ALL PRODUCT COMPONENTS ARE INTACT AND THE HYSTEROTOMY IS SECURELY SUTURED PRIOR TO INFLATING THE BALLOON. IF CLINICALLY RELEVANT, THE ABDOMEN MAY REMAIN OPEN UPON INFLATION OF THE BALLOON TO CLOSELY MONITOR UTERINE DISTENTION AND CONFIRM THE HYSTEROTOMY CLOSE. NOTE: IF CLINICALLY RELEVANT, A B-LYNCH COMPRESSION SUTURE MAY BE USED IN CONJUNCTION WITH THE BAKRI POSTPARTUM BALLOON. BALLOON REMOVAL NOTE: THE TIMING OF THE BALLOON REMOVAL SHOULD BE DETERMINED BY THE ATTENDING CLINICIAN UPON EVALUATION OF THE PATIENT ONCE BLEEDING HAS BEEN CONTROLLED AND THE PATIENT HAS BEEN STABILIZED. THE BALLOON MAY BE REMOVED SOONER UPON THE CLINICIAN'S DETERMINATION OF HEMOSTASIS. THE MAXIMUM INDWELL TIME IS 24 HOURS. HOW SUPPLIED UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. ALTHOUGH THE COMPLAINT DEVICE WAS INFLATED WITH FAR MORE FLUID THAN THE MAXIMUM INFLATION VOLUME INSTRUCTED IN THE IFU AND WAS LEFT INDWELLING 12 HOURS LONGER THAN THE MAXIMUM TIME INSTRUCTED IN THE IFU, THE PHYSICIAN'S FAILURE TO FOLLOW THE IFU IS NOT LIKELY THE CAUSE OF THE REPORTED EVENT. THE CAUSE OF THE EVENT CANNOT BE TRACED TO THE COMPLAINT DEVICE AND WAS MOST LIKELY RELATED TO PATIENT ANATOMY. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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 PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 21AUG2019.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K170622. 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

    IN THE JOURNAL ARTICLE ¿WHICH UTERINE SPARING TECHNIQUE SHOULD BE USED FOR UTERINE ATONY DURING CESAREAN SECTION?¿ THE BAKRI BALLOON OR THE B-LYNCH SUTURE? PUBLISHED IN THE ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2016) 294:511-517 BY KAYA, GURLAP, TUTEN, ET. AL, AND THE ORIGINAL STUDY ARTICLE PROVIDED BY DR. KAYA VIA EMAIL UPON REQUEST FOR ADDITIONAL INFORMATION ¿BALLOON TAMPONADE FOR MANAGEMENT OF POSTPARTUM UTERINE HEMORRHAGE¿ BY KAYA, TUTEN, DAGLER, ET. AL PUBLISHED IN THE JOURNAL OF PERINATAL MEDICINE (2014), IT IS REPORTED IN A STUDY OF 45 WOMEN EXPERIENCING POSTPARTUM HEMORRHAGE (PPH) RESISTANT TO MEDICAL TREATMENT THE BAKRI "FAILED" IN ELEVEN WOMEN (REMAINING 10 CASES REPORTED IN PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), PATIENT IDENTIFIER (B)(6), AND PATIENT IDENTIFIER (B)(6)). IN THE STUDY (AND ADDITIONAL INFORMATION PROVIDED BY DR. KAYA), BAKRI FAILURE WAS DEFINED AS FAILURE TO STOP BLEEDING WITHIN 15 MINUTES AFTER " BALLOON INFLATION DESPITE AN ADEQUATE AMOUNT OF SALINE INFUSION WITH OCCUPATION OF THE WHOLE UTERINE CAPACITY." PER DR. KAYA ¿I HAVE NEVER ENCOUNTERED ANY LEAKAGE OR RUPTURE OF BALLOON WITH HIGH INFLATION VOLUMES MORE THAN 500 ML UP TO 1300 ML.¿ PRIOR TO BAKRI PLACEMENT, ALL WOMEN IN THE STUDY WERE TREATED MEDICALLY WITH OXYTOCIN [40 IU IN 500ML OF NORMAL SALINE AT THE RATE OF 125ML/H (166MU/MIN) INTRAVENOUSLY]. IN THE CASES WHERE UTERINE ATONY WAS UNRESPONSIVE TO THE STANDARD OXYTOCIN REGIMEN, UTERINE MASSAGE AND BIMANUAL MASSAGE; THE PATIENTS WERE GIVEN ERGOMETRINE (INTRAMUSCULARLY 0.25-0.5MG), AND MISOPROSTOL (0.8-1MG RECTALLY). IN THIS CASE, A (B)(6) YEARS-OLD GRAVIDA 4, PARITY 3 WOMAN WITH A HISTORY OF 3 PREVIOUS VAGINAL DELIVERIES UNDERWENT EMERGENCY CESAREAN SECTION DUE TO ABLATIO PLACENTA (ABRUPTIO PLACENTA) IN THE (B)(6) WEEK OF GESTATION AND EXPERIENCED POSTPARTUM HEMORRHAGE DUE TO UTERINE ATONY, COUVELAIRE UTERUS, AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). FETAL WEIGHT WAS 4100 GM (MACROSOMIA).. MEDICAL TREATMENT AS DEFINED ABOVE FAILED AND A BAKRI WAS PLACED AND INFLATED TO 1300 ML. THE BAKRI FAILED TO STOP BLEEDING AND AN INTERNAL ILIAC ARTERY LIGATION WAS PERFORMED WHICH HALTED BLEEDING. THE ESTIMATED VOLUME OF BLOOD LOSS DURING SURGERY WAS 4500 ML. THE PATIENT WAS GIVEN 5 UNITS OF PACKED RED BLOOD CELLS (PRBC), AND 5 UNITS OF FRESH FROZEN PLASMA (FFP). THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) FOR TWO DAYS AND FOLLOW-UP WAS UNEVENTFUL. THE BAKRI WAS LEFT IN PLACE FOR 36 HOURS, AND THE 24TH HOUR DRAINAGE WAS 400ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707631 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O