BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13338274 · Received January 24, 2022

    Report

    Report Number
    3017425145-2021-00046
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    December 13, 2021
    Report Date
    January 12, 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

    LOT NUMBER IS NOT CURRENTLY AVAILABLE FOR THIS EVENT. REQUEST SENT TO SITE FOR LOT NUMBER ON DECEMBER 14, 2021, AND ON JANUARY 10, 2022, NO RESPONSE TO THIS REQUEST TO DATE. A GOOD FAITH EFFORT TO OBTAIN LOT NUMBER HAS BEEN ATTEMPTED. THIS REPORT WILL BE AMENDED IF WE RECEIVE ADDITIONAL INFORMATION REGARDING THIS EVENT. JADA WAS USED AS A TREATMENT INTERVENTION AS PART OF THE CARE OF A CRITICALLY ILL PATIENT EXPERIENCING PPH FOLLOWING A PLACENTAL ABRUPTION AND DIC. 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." ADDITIONAL WARNINGS PROVIDED ON THE JADA LABELING STATE 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." PRECAUTIONS FOR JADA INCLUDE THE FOLLOWING STATEMENTS, "JADA SHOULD NOT BE LEFT WITHIN THE UTERUS FOR LONGER THAN 24 HOURS DUE TO THE POSSIBILITY OF AN ADVERSE TISSUE REACTION OR INFECTION" AND "THE SAFETY AND EFFECTIVENESS OF THE USE OF JADA IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC) HAVE NOT BEEN EVALUATED." THERE IS NO REPORT OR EVIDENCE THAT SUGGESTS A DEVICE MALFUNCTION OCCURRED. THE JADA SYSTEM APPEARED TO BE WORKING AS NORMAL WITH EVACUATION OF BLOOD INTO THE CANISTER AND TONE FELT IN THE UTERUS. THE PATIENT'S BLEEDING WAS CONTROLLED. WE ARE UNABLE TO DETERMINE BASED ON THE INFORMATION PROVIDED IF THE DIC OR IF THE PATIENT'S CRITICALLY ILL STATUS THAT REQUIRED INTUBATION TO MEDICALLY STABILIZE HER OCCURRED BEFORE OR AFTER JADA TREATMENT WAS INITIATED. MEDICAL INTERVENTIONS WERE NECESSARY TO STABILIZE THIS CRITICALLY ILL PATIENT. BASED ON THE LACK OF INFORMATION FOR THIS EVENT, WE ARE UNABLE TO DETERMINE IF THE PATIENT'S DIAGNOSIS OF DIC AND THE INTERVENTION OF INTUBATION TO STABILIZE HER CRITICAL CONDITION PRE-EXISTED JADA USE. THEREFORE, WE ARE REPORTING THIS AS A MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    ONE (B)(6) 2021, ALYDIA HEALTH EMPLOYEE RECEIVED A PHONE CALL FROM A HEALTH CARE PROVIDER (MD) REGARDING A PATIENT THAT WAS TRANSFERRED FROM ANOTHER HOSPITAL THAT AT THE TIME OF THE CALL HAD A JADA IN PLACE FOR 34 HOURS. THE MD CALLED TO INQUIRE IF THE JADA SYSTEM INSTRUCTIONS FOR USE STATEMENT REGARDING 24-HOUR MAXIMUM INSERTION WAS AN "ARBITRARY NUMBER". THERE ARE VERY LIMITED DETAILS THAT ARE KNOWN REGARDING THIS EVENT. ON (B)(6) 2021, ALYDIA HEALTH EMPPLOYEE PROVIDED THE FOLLOWING INFORMATION BASED ON HER PHONE CALL EARLIER THAT MORNING WITH THE MD. THE MOTHER IS A (B)(6) WOMAN WITH ONE PREVIOUS DELIVERY. THIS PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL INTO THE CARE OF THE MD "A FEW HOURS" BEFORE THE CALL TO ON (B)(6) 2021. THE PATIENT SUFFERED A PLACENTAL ABRUPTION AND FETAL DEMISE WITH THIS PREGNANCY. THE PATIENT HAD ABRUPTIO PLACENTAE, SEVERE HEMORRHAGE, DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND WAS INTUBATED IN THE ICU . THE MD FELT THAT THE PATIENT HAD RECENTLY IMPROVED , DIC HAD RESOLVED, BUT SHE WOULD NOT SURVIVE AN EXPLORATORY LAPAROTOMY. SHE RELAYED THAT DOCUMENTATION STATED THE PATIENT INITIALLY BLED 700 ML, THEN 200 ML, BUT WAS UNAWARE IF THESE BLEEDING AMOUNTS WERE PRE OR POST JADA INSERTION. SHE OBSERVED THAT IN THE PRIOR FEW HOURS, THIS PATIENT HAD BLED LESS THAN 100ML INTO THE JADA CANISTER. SHE EXPRESSED CONCERN TO REMOVE THE JADA BECAUSE SHE FELT IF BLEEDING DID RESUME, SHE WOULD NOT BE ABLE TO RE-INSERT A JADA DUE TO THE PATIENT'S CONDITION OF "SWELLING ." THE PATIENT'S UTERUS WAS FIRM, AND THE PATIENT WAS BEING ADMINISTERED ANTIBIOTICS. DURING THIS CALL TO ALYDIA HEALTH, SHE EXPRESSED UNDERSTANDING THAT THE INSTRUCTIONS FOR USE STATE 24-HOUR MAXIMUM INSERTION AND WANTED TO KNOW IF THAT WAS AN "ARBITRARY NUMBER." SHE VERBALIZED UNDERSTANDING OF THE INSTRUCTIONS FOR USE, AND USING HER MEDICAL JUDGEMENT, PLANNED TO DISCONNECT THE VACUUM, REMOVE THE FLUID FROM THE SEAL AND MONITOR THE PATIENT. ON DECEMBER 14, 2021, THE MD PROVIDED THE FOLLOWING UPDATE TO ALYDIA HEALTH VIA TEXT MESSAGE. THE JADA DEVICE WAS LEFT IN-DWELLING FOR 36 HOURS AND REMOVED SUCCESSFULLY, NO FURTHER BLEEDING WAS REPORTED FOR THIS PATIENT. THE PATIENT WAS STILL VERY ILL, BUT BLEEDING WAS CONTROLLED. THE MD STATED REGARDING JADA, "I DID NOT PLACE IT, BUT I'M PRETTY SURE WITHOUT IT SHE WOULD'VE NEEDED A HYSTERECTOMY." SHE DID NOT PROVIDE ANY FURTHER INFORMATION OR CLARIFICATION ON THE TIMING OF JADA INTERVENTION, BLOOD LOSS PRE AND POST JADA, PREVIOUS INTERVENTIONS BEFORE JADA WAS INSERTED, THE TIMING OF ANY DIAGNOSIS OR THE TIMING OF ANY INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662072 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA-1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other