BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CERVICAL RIPENING BALLOON

    MDR report key: 1068216 · Received June 30, 2008

    Report

    Report Number
    1825146-2008-00023
    Event Type
    Death
    Date Received
    June 30, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 17, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    MCR
    PMA / PMN Number
    K040625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PROPER EVAL CANNOT BE PERFORMED DUE TO THE PRODUCT BEING DISPOSED OF FOLLOWING REMOVAL. INFO RECEIVED TO DATE INDICATES THE PT HAD 3-4 PREVIOUS MISCARRIAGES; THIS PREGNANCY WAS THE FIRST LIVE BIRTH. THE PT CAME TO THE HOSPITAL THE NIGHT BEFORE TO HAVE THE BALLOON PLACED AND BEGIN THE RIPENING OF THE CERVIX. THE BALLOON WAS PLACED IN THE PT, AND SHE WAS SENT HOME. THE NEXT MORNING, THE PT RETURNED TO HAVE THE BALLOON REMOVED AS WELL AS A VAGINAL EXAM. THE HOSPITAL WAS EXPERIENCING SEVERAL PTS IN ACTIVE LABOR AND ADVISED THE PT TO GO TO A FAMILY PRACTICE PHYSICIAN WHO ALSO TAKES SOME OBSTETRICAL CALLS. THE PHYSICIAN REMOVED AND DISPOSED OF THE BALLOON AROUND 9-9:30 AM AND INDICATED THE PT WAS APPROX. 4-5 CM DILATED WITH INTACT MEMBRANES. AT 4:32 PM, THE PT WAS ADMITTED TO THE HOSPITAL'S LABOR AND DELIVERY WARD. LATER, THE PT ADMINISTERED PITOCIN AND HAD AN AMNIOTOMY PERFORMED TO INDUCE LABOR; AMNIOTOMY PERFORMED AT 6:15 PM. FOLLOWING THE AMNIOTOMY, EVIDENCE PRESENTED OF CORD PROLAPSE. THEREFORE, THE PHYSICIAN QUICKLY MOVED THE PT TO EMERGENCY CESAREAN SECTION. THE CESAREAN SECTION WAS PERFORMED BY AN OBSTETRICIAN. THE BABY WAS SAFELY DELIVERED, HOWEVER THE MOTHER SOON 'CRASHED'. THE PT DID NOT RECOVER AND EXPIRED ON THE TABLE. THE PRESUMED DIAGNOSIS IS AMNIOTIC FLUID EMBOLISM, HOWEVER THAT HAS NOT BEEN CONFIRMED AND AN AUTOPSY WAS PERFORMED. TWO COOK GROUP PHYSICIANS (WHICH INCLUDE AN OBSTETRICIAN) HAVE REVIEWED THE FILE INFO AND HAVE INDICATED THAT THE CERVICAL RIPENING BALLOON WAS LIKELY NOT THE CAUSE OF THE PT DEATH PRIMARILY BASED UPON THE FACT THAT THE BALLOON WAS REMOVED APPROX. 9-10 HOURS PRIOR TO THE CESAREAN SECTION. IT WAS ALSO NOTED THAT WHEN THE BALLOON WAS REMOVED, THE MEMBRANES WERE NOT RUPTURED. AND THE PT WAS JUDGED TO NOT BE IN ACTIVE LABOR. SEVERAL HOURS PRIOR TO THE CESAREAN SECTION, THE VASCULAR SYSTEM WOULD NOT HAVE BEEN IN A COMPROMISED STATE, PARTICULARLY IN THE AREA OF THE CERVIX THAT WOULD HAVE ALLOWED FOR INTRUSION OF AMNIOTIC FLUID OR OTHER DEBRIS, AS THE PRELIMINARY CAUSE OF DEATH WAS NOTED AS AN AMNIOTIC FLUID EMBOLISM. AS AN ADD'L NOTE, THERE ARE SEVERAL CLINICAL REFERENCES THAT INDICATE BOTH CORD PROLAPSE AND CESAREAN SECTION BEING POSITIVELY ASSOCIATED WITH AMNIOTIC FLUID EMBOLISM. WE ARE CURRENTLY INVESTIGATING THIS SITUATION AND WILL UPDATE THE FDA AS ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER STATES: WE HAVE HAD A RECENT MATERNAL DEATH MOST LIKELY DUE TO AN AMNIOTIC FLUID EMBOLUS. WE ARE STILL WAITING FOR THE FINAL AUTOPSY REPORT. SHE WAS BEING INDUCED BY THE CERVICAL RIPENING BALLOON WHICH WAS PLACED THE NIGHT BEFORE HER INDUCTION. CAN YOU DO SOME RESEARCH ON THIS AND LET ME KNOW IF THE RIPENING BALLOON CAN BE DIRECTLY LINKED TO AFE. I KNOW IN THE WARNING IT STATES "CONCURRENT USE WITH THE BALLOON AND PROSTAGLANDINS CAN CAUSE AFE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CERVICAL RIPENING BALLOON CERVICAL DILATOR MCR COOK UROLOGICAL, INC. NA U1636461

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death