BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8015096 · Received October 29, 2018

    Report

    Report Number
    1820334-2018-03129
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    September 29, 2018
    Report Date
    November 9, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    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 AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE BAKRI TAMPONADE BALLOON CATHETER RETURNED FOR INVESTIGATION. RETURNED PACKAGING CONFIRMS LOT NUMBER 8481286. FUNCTIONAL TESTING DETERMINED THERE IS A LEAK IN THE BALLOON MATERIAL. VISUAL EXAMINATION NOTED A CUT IN THE BALLOON MATERIAL WHERE THE LEAK OCCURRED. IT IS POSSIBLE, THE BALLOON MATERIAL WAS PENETRATED BY A SHARP INSTRUMENT CAUSING THE CUT IN THE BALLOON MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS INCIDENT. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT FOR COMPLAINT DEVICE LOT NUMBER 8481286. 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 RETURNED BAKRI BALLOON WAS FOUND TO BE OUT OF SPECIFICATION, AS A CUT WAS FOUND IN THE BALLOON MATERIAL. IT IS POSSIBLE THE BALLOON MATERIAL WAS PENETRATED BY A SHARP INSTRUMENT DURING THE PROCEDURE, CAUSING THE BALLOON TO LEAK. THE CAUSE OF THE CUT COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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

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

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510K # 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, DURING THE PROCESS OF CESAREAN SECTION, THE PATIENT SUFFERED POSTPARTUM HEMORRHAGE DUE TO DANGEROUS PLACENTA PREVIA. THE PHYSICIAN SUTURED THE UTERUS INCISION AND PROCESS B-LYNCH SUTURE TO HEMOSTASIS, BUT THE EFFECT WAS UNSATISFACTORY. THE AMOUNT OF BLEEDING REACHED 3000 ML BEFORE PLACEMENT OF THE BAKRI TAMPONADE BALLOON CATHETER TO STOP BLEEDING. THE PHYSICIAN PLACED THE BALLOON WITH SPONGE FORCEPS INTO THE UTERINE CAVITY THROUGH THE VAGINA, THEN INJECTED WITH 250 ML SALINE, BUT INEFFECTIVE. THEN THE PHYSICIAN CONTINUED TO INJECT WITH 50 ML OF SALINE, BUT THE HEMOSTATIC EFFECT WAS INEFFECTIVE. THE PHYSICIAN REMOVED THE DEVICE AND FOUND THE BALLOON WAS LEAKING. THEN THE PHYSICIAN CHANGED TO ANOTHER NEW DEVICE AND INJECTED 250ML SALINE AND THE PATIENT HAD SUCCESSFUL HEMOSTASIS. IT WAS REPORTED, THE PATIENT WAS AT (B)(6) GESTATION AND GRAVIDA 1/PARA 1. THE PATIENT LOST APPROXIMATELY 100 ML OF BLOOD AFTER BALLOON PLACEMENT, SHE DID NOT RECEIVE BLOOD OR BLOOD PRODUCTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853345 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8481286 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR SPONGE FORCEPS