BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8400704 · Received March 7, 2019

    Report

    Report Number
    1820334-2019-00590
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 12, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT IS REPORTED THAT A BAKRI TAMPONADE BALLOON CATHETER (J-SOS-100500, LOT 9091132) LEAKED FROM THE THREE-WAY STOPCOCK WHILE THE PATIENT WAS BEING MOVED TO A HOSPITAL WARD AFTER DEVICE PLACEMENT RESULTING IN DEFLATION OF THE BALLOON. THE PHYSICIAN INJECTED MORE WATER INTO THE BALLOON, TIGHTENED THE STOPCOCK FIRMLY, AND OBSERVED THAT THE LEAKING HAD STOPPED. THE PROCEDURE WAS COMPLETED USING THE COMPLAINT DEVICE. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, REVIEW OF TRENDS, REVIEW OF IFU, AND QUALITY CONTROL DATA. DEVICE MASTER RECORD (DMR) REVIEW IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DMR. THE FOLLOWING CONTROLS ARE IN PLACE TO ADDRESS THE REPORTED FAILURE MODE: QC_J-SOS (D00132907) "BAKRI POST-PARTUM BALLOON" VER7 INCLUDES THE FOLLOWING: SECTION 4.1: "INSPECTION" SECTION 4.1.1: "FUNCTIONALITY OF PRODUCT ¿ FREQUENCY: INSPECT ALL STEPS 100% UNLESS OTHERWISE SPECIFIED. REFERENCE QSI03_05." SECTION 4.1.1.1: "REMOVE AND DISCARD BOTH SHIPPING CAPS FROM STOPCOCK. ATTACH STOPCOCK TO INFLATION LUMEN. POSITION STOPCOCK IN OPEN POSITION PER DRAWING." SECTION 4.1.1.2: "ASSURE TIP IS CLOSED, ROUND AND SMOOTH." SECTION 4.1.1.3: "VISUALLY ASSURE INSIDE DIAMETER OF CATHETER TO BE FREE OF OCCLUSIONS." SECTION 4.1.1.4: "CHECK TO BE FREE OF DEBRIS, DISCOLORATION, AND SURFACE IMPERFECTIONS." SECTION 4.1.1.5: "ASSURE BALLOON AND CATHETER ARE FREE OF EXCESS GLUE." COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_J-SOSR_REV2 ¿BAKRI POSTPARTUM BALLOON,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS "THIS DEVICE INTENDED AS A TEMPORARY MEANS OF ESTABLISHING HEMOSTASIS IN CASES INDICATING CONSERVATIVE MANAGEMENT OF POSTPARTUM UTERINE BLEEDING." "THE BAKRI POSTPARTUM BALLOON IS INDICATED FOR USE IN THE EVENT OF PRIMARY POSTPARTUM HEMORRHAGE WITHIN 24 HOURS OF DELIVERY." "THE DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN 24 HOURS." "PATIENTS IN WHOM THIS DEVICE IS BEING USED SHOULD BE CLOSELY MONITORED FOR SIGNS OF WORSENING BLEEDING AND/OR DISSEMINATED INTRAVASCULAR COAGULATION (DIC). IN SUCH CASES, EMERGENCY INTERVENTION PER HOSPITAL PROTOCOL SHOULD BE FOLLOWED." "PATIENT MONITORING IS AN INTEGRAL PART OF MANAGING POSTPARTUM HEMORRHAGE. SIGNS OF DETERIORATED OR NON-IMPROVING CONDITION SHOULD LEAD TO A MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF PATIENT UTERINE BLEEDING." INSTRUCTIONS "NOTE: REMOVE THE STOPCOCK TO AID IN PLACEMENT AND REATTACH PRIOR TO FILLING BALLOON." HOW SUPPLIED "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." DEVICE HISTORY RECORD (DHR) REVIEW IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE DHR. THE DHR FOR LOT 9091132 RECORDS 2 NON-CONFORMANCES. 474 - SURFACE DEFECT 23.5 CM FROM PROXIMAL END, 1 543 - NOT KEYED OUT IN PROD, 1 COOK CONCLUDED THAT THE RECORDED NON-CONFORMANCES ARE NOT RELATED TO THIS INCIDENT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COMPLAINT HISTORY REVIEW A TRACKWISE SEARCH REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER (9091132). CONCLUSION A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED. THE RISK ANALYSIS FOR THIS FAILURE MODE, QERA 1750, WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    HOLD CM 4/12 ADDITIONAL/CLARIFYING INFORMATION: AFTER "WATER DRAINED FROM THE BALLOON SINCE THE THREE-WAY STOPCOCK WAS LOOSENED WHILE THE PATIENT WAS BEING MOVED TO A HOSPITAL WARD AFTER DEVICE PLACEMENT, WHICH RESULTED IN DEFLATION OF THE BALLOON," THE STOPCOCK WAS TIGHTENED FIRMLY AFTER WATER WAS INJECTED AGAIN. AS LEAKAGE STOPPED AFTER THAT, THE PROCEDURE WAS FINISHED WITH THE COMPLAINT DEVICE.¿

    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 DURING ARREST OF HEMORRHAGE USING THE BAKRI TAMPONADE BALLOON CATHETER, WATER DRAINED FROM THE BALLOON BECAUSE THE THREE-WAY STOPCOCK WAS LOOSENED WHILE THE PATIENT WAS BEING MOVED TO A HOSPITAL WARD AFTER DEVICE PLACEMENT, WHICH RESULTED IN DEFLATION OF THE BALLOON. WATER DRAINED FROM THE BALLOON SINCE THE THREE-WAY STOPCOCK WAS LOOSENED WHILE INJECTING WATER IN ORDER TO INFLATE THE BALLOON. THE STOPCOCK WAS TIGHTENED FIRMLY, THEN LEAKAGE STOPPED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE USER(S) DID NOT VERIFY IF THE LOCK WAS FIRMLY TIGHTENED PRIOR TO USE. WHEN THE USER TOUCHED THE LOCK WHEN LEAKAGE OCCURRED, HE/SHE FELT THAT THE LOCK WAS LOOSE. THREADS OF THE FEMALE AND MALE LOCKS COULD BE ENGAGED PROPERLY WHEN THESE WERE TIGHTENED. ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION IS AVAILABLE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANIES THIS DEVICE: PRECAUTIONS: THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN OBSTETRICS AND GYNECOLOGICAL TECHNIQUES. INSTRUCTIONS FOR USE: NOTE: REMOVE THE STOPCOCK TO AID IN PLACEMENT AND REATTACH PRIOR TO FILLING BALLOON. NOTE: ENSURE THAT ALL PRODUCT COMPONENTS ARE INTACT AND THE HYSTEROTOMY IS SECURELY SUTURED PRIOR TO INFLATING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192841 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 9091132 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1