BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8347890 · Received February 18, 2019

    Report

    Report Number
    1820334-2019-00373
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 8, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS. ONE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS LOT NUMBER 9178627. VISUAL EXAMINATION NOTES A 6CM SPLIT IN THE BALLOON MATERIAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED THAT WOULD BE RELATED TO THE REPORTED FAILURE. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 9178627. THE COMPLAINT WAS CONFIRMED BASED ON EVALUATION OF THE RETURNED DEVICE. THE DEVICE MAY HAVE BEEN DAMAGED DURING THE PROCEDURE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS AVOID EXCESSIVE FORCE WHEN INSERTING THE BALLOON INTO THE UTERUS. THE CAUSE OF THE EVENT IS UNKNOWN. 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

    NO NEW EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    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 AFTER DELIVERY, THE DOCTOR USED THE BAKRI BALLOON TO MANAGE POST PARTUM HEMORRHAGE (PPH) INSIDE THE UTERUS. THE DOCTOR INSERTED THE BALLOON INSIDE THE UTERUS AND WANTED TO INFLATE BALLOON UP TO 300 CC USING A 60ML SYRINGE. DURING INFLATION, THE DOCTOR FOUND THAT THERE WAS A LEAKAGE IN THE BALLOON. THEREFORE, THE DOCTOR HAD TO DEFLATE AND REMOVE THE BALLOON. ANOTHER BAKRI TAMPONADE BALLOON CATHETER WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. NO UNINTENDED PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141652 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 9178627 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 60ML SYRINGE