BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 7898057 · Received September 21, 2018

    Report

    Report Number
    1820334-2018-02826
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    December 3, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE (3191) NO CODE AVAILABLE = HYSTERECTOMY BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. A REVIEW OF THE DEVICE HISTORY OBSERVED NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8664116. THIS DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH CONTAINS THE FOLLOWING RELEVANT INFORMATION: THE BAKRI POSTPARTUM BALLOON IS A SILICONE BALLOON CATHETER WITH A MAXIMUM INFLATION VOLUME OF 500ML. THE RAPID INSTILLATION COMPONENTS INCLUDE POLYMER TUBING WITH AN IV GAB SPIKE AND THREE-WAY VALVE. INTENDED USE: THIS DEVICE IS INTENDED TO PROVIDE TEMPORARY CONTROL OR REDUCTION OF POSTPARTUM UTERINE BLEEDING WHEN CONSERVATIVE MANAGEMENT IS WARRANTED. PRECAUTIONS AVOID EXCESSIVE FORCE WHEN INSERTING THE BALLOON INTO THE UTERUS. WARINING: ALWAYS INFLATE THE BALLOON WITH STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. HOW SUPPLIED STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THERE WAS NO INFORMATION PROVIDED SURROUNDING THE PREPARATION OF THE DEVICE. ACCORDING TO THE CUSTOMER, A 20ML SYRINGE WAS USED TO INFLATE THE BALLOON. THE SYRINGE ENCLOSED WITH THE DEVICE IS A 60ML SYRINGE. IT IS UNCLEAR WHY THE 20ML SYRINGE WAS USED. IT IS NOT KNOWN IF IT WAS COMPATIBLE WITH THE J-SOSR-100500 OR IF IT MET ITS MANUFACTURING SPECIFICATIONS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THERE WERE NO ANOMALIES IDENTIFIED IN THE DEVICE HISTORY RECORD. PROCESS CONTROLS ARE IN PLACE TO INSPECT THE PRODUCT BEFORE SHIPMENT. A CONCLUSION AS TO THE CAUSE OF THE REPORTED ISSUE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 28NOV2018. THE PATIENT RECEIVED THE FOLLOWING MEDICATIONS PRIOR TO THE BALLOON INSERTION: MISOPROSTOL 25 MCG INTRAVAGINAL, OXITOCINA 10 UI AT THE BIRTH, 10 UI INTRAMIOMETRIALES, 40 UI - 500 CC SSN, AND METILERGOMETRINA 0.2 MG TWO DOSES AS REPORTED, THE BALL DID NOT INFLATE AND IT WAS BROKEN. WHEN ASKED WHY THEY DIDN¿T USE THE 60ML SYRINGE WHICH CAME IN THE KIT, THE RESPONSE WAS ¿INFORMATION IS NOT AVAILABLE¿. TRANSVAGINAL METHOD IS USED FOR BAKRI BALLOON INSERTION. THERE WERE NO ISSUES REPORTED DURING THE INSERTION OF THE DEVICE. PATIENT WITH DIAGNOSES OF UNSPECIFIED MATERNAL HYPERTENSION, HIGH-RISK PREGNANCY, STOPPING DILATION IN THE PROCESS OF DELIVERY, FOR WHICH THEY SCHEDULED AN EMERGENCY CAESAREAN SECTION. NO BLEEDING IS DESCRIBED BEFORE THE CESAREAN. THE CUSTOMER REPORTED A NEW BAKRI WAS INTRODUCED AFTER THE FIRST ONE FAILED BUT THEY ENDED UP DOING A HYSTERECTOMY. WHEN ASKED WHEN THAT WAS PERFORMED IN RELATION TO THE C-SECTION AND BAKRI PLACEMENT, THE RESPONSE WAS ¿IT IS DESCRIBED PRIOR TO THE INTRODUCTION OF THE BAKRI BALLOON, DURING CESAREAN DELIVERY (SEGMENTAL HYSTEROTOMY)¿. A TRANSFUSION OF 2 UNITS OF GLOBULAR CONCENTRATE O NEGATIVE WAS PERFORMED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 23OCT2018. THE COOK BAKRI BALLOON WAS USED TO TREAT HEMORRHAGE AFTER CESAREAN SECTION BY VAGINAL TAMPONADE. THE BALLOON WAS INFLATED TO THE RECOMMENDATIONS LISTED IN THE INSTRUCTIONS FOR USE (IFU). A 20CC SYRINGE WAS USED TO FILL THE BALLOON, FORCEPS WERE NOT USED IN PLACEMENT OF THE DEVICE. THE "BALL" WAS NEVER INFLATED, THE DAMAGE ON THE TIP OF THE BALL. THE PATIENT WAS AT 37 WEEKS GESTATION AND HAD LOST APPROXIMATELY 1500CC OF BLOOD PRIOR TO BALLOON PLACEMENT, 2000-2300CC APPROXIMATED TOTAL BLOOD LOSS. A HYSTERECTOMY WAS PERFORMED DUE TO UNCONTROLLED BLEEDING REQUIRING INTENSIVE CARE DUE TO HYPOVOLEMIC SHOCK. THE PATIENT WAS DISCHARGED FROM THE CLINIC.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) #: K170622. (B)(4). 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

    IT WAS REPORTED THAT DURING USE OF THE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS, THE BALL HAS BROKEN IN THE PART OF THE PUMP. THE DOCTOR, REMOVED THE BALL AND A NEW ONE WAS INTRODUCED. THE DEVICE HAS BEEN DISCARDED BY THE USER FACILITY DUE TO CONTAMINATION. AS REPORTED, NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY, NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL PATIENT, DEVICE AND EVENT DETAILED INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN FORTHCOMING AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739456 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 8664116 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| O| S