BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 14044954 · Received April 7, 2022

    Report

    Report Number
    3017425145-2022-00056
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 11, 2021
    Report Date
    April 7, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE OVERALL INFORMATION CURRENTLY AVAILABLE FOR THIS REPORT, A POSSIBLE CONTRIBUTING OR CAUSAL ROLE OF THE JADA SYSTEM FOR THE NEED OF ESCALATING TREATMENT (UTERINE ARTERY EMBOLIZATION) TO PRECLUDE PERMANENT BODY DAMAGE/IMPAIRMENT CANNOT BE EXCLUDED. PER THE JADA SYSTEM IFU, "SIGNS OF PATIENT DETERIORATION OR FAILURE TO IMPROVE INDICATE THE NEED FOR REASSESSMENT AND POSSIBLY MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF POSTPARTUM HEMORRHAGE (PPH)/ABNORMAL POSTPARTUM UTERINE BLEEDING.", "EVALUATE FOR LACERATIONS, RETAINED PRODUCTS OF CONCEPTION, OR OTHER CAUSES OF BLEEDING PRIOR TO USING JADA." AND "JADA IS NOT A SUBSTITUTE FOR SURGICAL MANAGEMENT AND FLUID RESUSCITATION OF LIFE-THREATENING PPH/ABNORMAL POSTPARTUM UTERINE BLEEDING." OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY WILL REPORT THIS CASE AS A SERIOUS INJURY MDR.

    Description of Event or Problem · 0

    ALYDIA HEALTH RECEIVED A JADA EXPERIENCE SURVEY (JES) ON 03/12/2022 AND HAD A CONVERSATION WITH ONE OF THE SITES HEALTH CARE PROVIDERS IN WHICH ADDITIONAL INFORMATION WAS SHARED THAT WAS NOT PROVIDED ON THE JES. SHE STATED THAT "IT WAS A COMPLICATED CASE AND THEY ENDED UP USING THREE JADA DEVICES ON THE PATIENT. THE PATIENT ENDED UP LOSING A LARGE VOLUME OF BLOOD (ALMOST 3 LITERS) FROM A RAPID BLEED." THEY USED THE FIRST JADA, AND THE MANUAL SWEEP WAS CHALLENGING BECAUSE THE PATIENT DID NOT HAVE AN EPIDURAL. THE PATIENT CONTINUED TO BLEED, THEY REMOVED THE JADA AND TOOK THE PATIENT TO OR. THEY ENDED UP PLACING THE SECOND JADA THERE AND REMOVED AGAIN WITH CLOTS PRESENT. THE PATIENT ENDED UP GETTING A UTERINE ARTERY EMBOLIZATION AND AT SOME POINT, BEFORE OR AFTER, THEY PLACED THE THIRD JADA, AND IT WAS SUCCESSFUL. THE PATIENT WAS IN THE ICU, AND THEY ONLY HAD 35 ML OF BLOOD LOSS ONCE THE THIRD JADA WAS PLACED SUCCESSFULLY. THE HEALTH CARE PROVIDER SAID SHE "DOES NOT FEEL IT WAS A PROBLEM WITH THE DEVICE AND THAT THE PATIENT WAS BLEEDING RAPIDLY AND CLOTTING RAPIDLY". THE SITE DID NOT RECORD THE LOT NUMBERS, AND THE DEVICES WERE DISCARDED. THE JES DESCRIBES THIS PATIENT'S PPH STARTING WITHIN ONE HOUR AFTER A SPONTANEOUS VAGINAL DELIVERY. SHE RECEIVED CYTOTEC (1000MG) AND METHERGINE (200 MCG) AND TXA PRIOR TO JADA TREATMENT. SHE WAS NOTED AS HAVING LOST 800 ML OF BLOOD PRIOR TO JADA INITIATION. THE JADA WAS DOCUMENTED AS CONTROLLING THE PPH BLEEDING IN "1-5 MINUTES" AND THE AMOUNT OF BLOOD EVACUATED WITH JADA WAS NOTED AS "UNSURE" ON THE JES AND THE CERVICAL SEAL WAS FILLED WITH 60 ML OF STERILE FLUID. THERE IS NO MORE INFORMATION ON THIS CASE ON THE JES. THE SITE PROVIDED A BRIEF STATEMENT TO THE FOLLOW UP QUESTIONS FOR THIS CASE. THE HEALTH CARE PROVIDER STATED, "THERE WAS NO EXPLANATION OR REASON FOR THE CLOTTING AND THAT THE JADA WAS WORKING WELL, THEY WERE USING WALL SUCTION AT 80MMHG, BUT THE MOM WAS CLOTTING QUICKLY SO THAT HAD BEEN PART OF THE CHALLENGE." SHE STATED IT WAS A "CHALLENGING CASE AS THERE WAS ONLY ATONY OF THE LOWER UTERINE SEGMENT, BUT THE BLEEDING WAS MORE SIGNIFICANT THAN SHE WOULD EXPECT FOR THAT." SHE STATED SHE PLACED THE THIRD JADA WITH THE UTERINE ARTERY EMBOLIZATION, AND SHE FELT THAT "THE COMBINATION OF TREATMENT WAS PERFECT FOR MOM" AND SHE WAS "VERY PLEASED WITH JADA DESPITE THE EARLY DIFFICULTIES." THE SITE DOES NOT HAVE THE LOT NUMBER FOR THIS EVENT, A GOOD FAITH EFFORT TO OBTAIN THIS INFORMATION HAS BEEN ATTEMPTED. THE SITE HAS ALSO DISCARDED THE JADA USED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263782 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention