BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 7926420 · Received October 2, 2018

    Report

    Report Number
    1820334-2018-02877
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED USING WATER AND A SYRINGE. VISUAL EXAMINATION NOTED THE DEVICE LEAKS IN THE BOND. THE BALLOON MATERIAL HAS SEPARATED AT THE BOND. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 8938786. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): HOW SUPPLIED: UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE CAUSE FOR THIS SPECIFIC FAILURE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DEVICE CONFIRMED TO BE EN ROUTE TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 22NOV2018. AS REPORTED, THE ISSUE WITH THE BAKRI BALLOON HAPPENED AFTER A POST-PARTUM HEMORRHAGE. WHEN THE DOCTOR PLACED THE BALLOON, HE MENTIONED THAT HE FOLLOWED THE USUAL PROCEDURE AND HIS OWN EXPERIENCE. AFTER THE INSTILLATION OF THE BALLOON HE NOTICED A LEAKAGE (A CLEAR LIQUID). WHEN HE REMOVED THE DEVICE, HE NOTICED A HOLE IN THE STRUCTURE OF THE BALLOON. THE DEVICE COULD NOT APPLY PRESSURE ON THE VESSELS AND THIS LED TO A BIGGER LOSS OF BLOOD FOR THE PATIENT. INFORMED ON 28NOV2018 THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    UPDATE: ON 09NOV2018 ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN CONSIDERS THAT THE ISSUE HAD NO LINK WITH THE PATIENT BECAUSE THERE WAS A HOLE ON THE SURFACE OF THE BALLOON! HE NOTICED SOMETHING WAS WRONG WHEN A WHILE AFTER INSTALLATION OF THE BALLOON A LEAKAGE (A CLEARER LIQUID) OUT FROM THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE 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 INITIALLY REPORTED ON (B)(6) 2018, POST PARTUM HEMORRHAGE. BAKRI BALLOON PLACED. LEAK ++++, LEFT IN PLACE BUT UNDER ULTRASOUND, IT SHOWS EMPTY. PATENT WAS PREGNANT WITH TWINS. DECLARED TO (B)(6). DEVICE AVAILABLE. CLINICAL CONSEQUENCES: NONE. (B)(6) WAS RECEIVED FROM (B)(6) ON 20SEP2018. THE FOLLOWING INFORMATION WAS PROVIDED: TWIN PREGNANCY. HAEMORRHAGE 2 LITRES. ON (B)(6) 2018: HAEMORRHAGE DURING DELIVERY ON (B)(6) 2018: IMPLANT BAKRI. 0H33 IMPLANT ECHO: NOTHING TO DECLARE 1H30 LEAK +++. LEFT IN POSITION BUT ECHO EMPTY. POSE NO. 2. LEAKS OBSERVED NEAR THE BALLOON NEAR THE MANIFOLD. NO OBSERVED CLINICAL CONSEQUENCES. ON 25SEP2018 THE FOLLOWING INFORMATION WAS RECEIVED IN RESPONSE TO REQUESTS FOR ADDITIONAL INFORMATION. ON (B)(6) 2018 DURING A POST-PARTUM HEMORRHAGE TAMPONADE PROCEDURE USING THE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS, THERE WAS A LEAKAGE LOCATED AT THE JUNCTION BETWEEN THE BOTTOM OF THE BALLOON AND THE TUBE. THE BALLOON WAS EMPTY AT THE ULTRASOUND CONTROL. THERE WERE ADVERSE EFFECTS TO THE PATIENT. THE LEAKAGE OF THE BAKRI BALLOON HAS CAUSED A HIGHER VOLUME OF BLOOD TO THE PATIENT. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL EVENT AND PATIENT IMPACT/OUTCOME DETAILS, AT THIS TIME NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767365 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 8938786 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR