BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7810419 · Received August 23, 2018

    Report

    Report Number
    1820334-2018-02560
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    August 12, 2018
    Report Date
    October 9, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Adverse Event
    Yes
    Product Problem
    Yes
    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 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, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTED THE DEVICE HAS A 3.5 CM SPLIT IN THE BALLOON MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 8194291. THE CAUSE OF THE RUPTURED BALLOON COULD NOT BE DETERMINED HOWEVER IT IS FEASIBLE THE BALLOON WAS DAMAGED DURING THE PROCEDURE. 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 OF THE RUPTURED BALLOON COULD NOT BE DETERMINED HOWEVER IT IS FEASIBLE THE BALLOON WAS DAMAGED DURING THE PROCEDURE. THE RISK ANALYSIS FOR THE RUPTURE OR LEAKAGE OF THE BALLOON WAS REVIEWED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 24AUG2018. BLOOD PRODUCT WAS GIVEN TO THE PATIENT IN THE AMOUNT OF 600ML.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED, AFTER A CESAREAN SECTION, THE PATIENT SUFFERED POSTPARTUM HAEMORRHAGE DUE TO UTERINE ATONY. THE AMOUNT OF BLOOD LOSS REACHED 1000 ML BEFORE PLACING THE BAKRI TAMPONADE BALLOON CATHETER TO STOP THE BLEEDING. THE PHYSICIAN PLACED THE BALLOON INTO THE UTERINE CAVITY THROUGH THE INCISIONS AND THEN SUTURED THE INCISION. AFTER INJECTING 400 ML OF SALINE(50ML AT A TIME), THE PHYSICIAN PLANNED TO ADD AN ADDITIONAL 50ML OF SALINE INTO THE BALLOON, WHEN THE PHYSICIAN HEARD A SLIGHT POP AND NOTICED A LARGE AMOUNT OF LIQUID FLOWING OUT FROM VAGINA. THE PHYSICIAN REMOVED THE BALLOON AND FOUND THE BALLOON WAS RUPTURED IN LONGITUDINAL DIRECTION. THE PHYSICIAN USED ANOTHER BALLOON TO STOP THE BLEEDING SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. AS REPORTED, THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651139 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8194291 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other