BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13049554 · Received December 20, 2021

    Report

    Report Number
    3017425145-2021-00038
    Event Type
    Injury
    Date Received
    December 20, 2021
    Report Date
    December 20, 2021
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE UNCERTAIN IF EFFORTS WERE MADE TO REMOVE BLOOD CLOTS PRIOR TO JADA INSERTION, IF BLEEDING RESOLVED AFTER THE CLOTS WERE REMOVED, IF AN ULTRASOUND WAS CONDUCTED WHILE JADA WAS IN PLACE AND IF THAT IS HOW THEY DETERMINED THERE WERE LARGE CLOTS OR IF THEY NOTED THE CLOTS AFTER THEY REMOVED THE JADA DEVICE, AND WHETHER THEY NEEDED TO DO A D&C OR ANY ADDITIONAL TREATMENT TO CONTROL HER PPH AFTER JADA WAS REMOVED. JADA WAS USED AS A TREATMENT INTERVENTION WITH A PATIENT EXPERIENCING SEVERE PPH THAT UTEROTONICS HAD FAILED TO STOP AND THE PRESENCE OF LARGE CLOTS WAS NOTED. THE DEVICE LABELING STATES THE INDICATION FOR USE OF JADA IS "TO PROVIDE CONTROL AND TREATMENT OF ABNORMAL POSTPARTUM UTERINE BLEEDING OR HEMORRHAGE WHEN CONSERVATIVE MANAGEMENT IS WARRANTED" AND INSTRUCTIONS FOR USE STATE THE FOLLOWING: "EVALUATE FOR LACERATIONS, RETAINED PRODUCTS OF CONCEPTION, OR OTHER CAUSES OF BLEEDING PRIOR TO USING JADA." ALSO, WARNINGS PROVIDED ON THE JADA LABELING STATES THAT "FAILURE TO IMPROVE INDICATES THE NEED FOR REASSESSMENT AND POSSIBLY MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF PPH" AND "JADA IS NOT A SUBSTITUTE FOR SURGICAL INTERVENTION AND FLUID RESUSCITATION OF LIFE-THREATENING PPH." PPH IS A MEDICAL EMERGENCY, WITH PATIENT'S TREATMENT AND CONDITION CLOSELY MONITORED. IF THERE ARE BLOOD CLOTS NOTED AS PRESENT IN THE PATIENT'S UTERUS THAT REQUIRE SUCTION REMOVAL THE HEALTH CARE PROVIDER WILL NOTE THIS IMMEDIATELY. THE HEALTH CARE PROVIDER WILL THEN SELECT A TREATMENT APPROPRIATE TO REMOVE LARGE BLOOD CLOTS FROM THE PATIENT'S UTERUS IMMEDIATELY. WE ARE REPORTING THIS AS A DEVICE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. IN THIS EVENT, JADA WAS USED TO CONTROL SEVERE PPH WITH A PATIENT THAT PREVIOUS USE OF UTEROTONICS FAILED TO STOP THE PPH AND IN THE PRESENCE OF LARGE BLOOD CLOTS. THE INTERVENTION OF SUCTION WAS NECESSARY TO REMOVE LARGE BLOOD CLOTS. THERE IS NO DOCUMENTATION OF CONTINUED BLEEDING OR ESCALATION OF TREATMENT TO CONTROL PPH. AS WE ARE UNABLE TO RULE OUT THE USE OF JADA IN CONTRIBUTING TO THE NEED TO SUCTION LARGE BLOOD CLOTS OR BLOOD TRANSFUSION AFTER INSERTION, WE ARE REPORTING THIS AN MDR IN AN ABUNDANCE OF CAUTION. THIS REPORT WILL BE AMENDED IF WE RECEIVE ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT JADA "DID NOT WORK" FOLLOWING A POSTPARTUM HEMORRHAGE (PPH) OF 2009 ML AFTER AN UNSCHEDULED CESAREAN SECTION (C-SECTION). THE REPORTER NOTED THAT, "JADA SMALL SUCTION HOLES UNABLE TO REMOVE LARGE CLOTS" AND AN ADDITIONAL INTERVENTION OF "SUCTION REMOVAL OF UTERINE CLOTS." INFORMATION OBTAINED REGARDING THIS EVENT WAS LIMITED. THIS PATIENT'S BLEEDING STARTED 1-6 HOURS AFTER DELIVERY. SHE HAD A MEDICAL HISTORY OF PRIOR PPH, PREVIOUS C-SECTION, AND CURRENT LYME DISEASE. SHE HAD SPONTANEOUS RUPTURE OF MEMBRANES. SHE RECEIVED METHERGINE, CYTOTEC AND TXA PRIOR TO JADA TREATMENT. QUANTITATIVE BLOOD LOSS PRIOR TO JADA USE WAS 2009 ML AND AFTER USE OF JADA 929 ML. AFTER JADA TREATMENT SHE RECEIVED PACKED RED BLOOD CELLS (2 UNITS) AND "SUCTION REMOVAL OF UTERINE CLOTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946708 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA- 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention