MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA-1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Information has been received from an investigator concerning a (b)(6) year-old adult black/ african american (ethnic group: not hispanic or latino) female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada® system - a post-market registry".This report concerns 1 subject and 1 device.The subject's height was 167.6 centimeter (cm), weight was (b)(6) kilogram (kg), body mass index (bmi) 41.71 (no units provided).The subject's concurrent conditions included gravidity 10 (multigravida) and parity 8 (multiparous) and spontaneous abortion 2 (abortion spontaneous) by vaginal delivery 8 (delivery).The patient never experienced abnormal postpartum uterine bleeding or pph at previous deliveries.On (b)(6) 2022 at 07:35, the patient got admitted to hospital for delivery at 42 gestational age at delivery (presumably weeks) (unit not provided), and hemoglobin was found to be 11.4 (no units provided) at the time of admission.Oxytocin (pitocin) bolus was used for labor induction for delivery of infant for 5 hours and had vaginal delivery.She received epidural anesthesia for delivery and the patient delivered singleton at 14:51 on (b)(6) 2022 (after 7.27 hours of admission) with birthweight: (b)(6) grams.Bleeding post vaginal delivery was heavy.The interventions given were carboprost (hemabate) of 1 dose, misoprostol (cytotec), methylergometrine maleate (methergine) of 1 dose and txa (tranexamic acid) of 1 dose (the subject was not involved in txa study), to prior to use of vacuum-induced hemorrhage control system (jada system) and none were given at the time or after vacuum-induced hemorrhage control system (jada system) use.Intrapartum antibiotics were not given for pre-operative cesarean delivery.Postpartum antibiotics were given such as ceftriaxone (ancef) and azithromycin for vacuum-induced hemorrhage control system (jada system) use (prophylactic antibiotic therapy).On (b)(6) 2022 (the same day) at 15:20 (after 0.48 hours of placental delivery), the subject had vacuum-induced hemorrhage control system (jada system) insertion under ultrasound (us) guidance then bleeding well controlled for several minutes and at or (operation room) by doctor, to control pph (post-partum hemorrhage).It had controlled abnormal postpartum uterine bleeding or pph (post-partum hemorrhage), but then bleeding resumed around vacuum-induced hemorrhage control system (jada system) (device ineffective) with passage of a large amount of clots and the subject had total cumulative blood loss for the event was 4447 (unit unspecified).Additional doses of the following carboprost (hemabate) of 1 dose, misoprostol (cytotec), methylergometrine maleate (methergine) of 1 dose and intravenous (iv) txa (tranexamic acid) of 1 dose were given while vacuum-induced hemorrhage control system (jada system) treatment was ongoing or after vacuum-induced hemorrhage control system (jada system).A cumulative blood loss was 3260 (unit unspecified) was noted after delivery.The patient was examined under anesthesia in operation room (or), d&c (uterine dilation and curettage) and per ultrasound (us) to retained poc (products of conception).The time from vacuum connection to control of abnormal bleeding with vacuum-induced hemorrhage control system (jada system) was not achieved, and it did not control.Total amount of blood collected in canister during vacuum-induced hemorrhage control system (jada system) treatment was unknown.Due to the continued bleeding around the vacuum-induced hemorrhage control system (jada system), and the cervix was re-examined.There was a tear on the right side of the cervix that was minimally oozing but was repaired with 3-0 vicryl.During this time, the bleeding had significantly slowed.The patient then began to bleed again.There was no uterine compression suture used for this bleeding event.The vacuum was not reapplied during/after any verification step for additional bleeding.Due to the recurrence of the bleeding event after initial control and vacuum-induced hemorrhage control system (jada system) removed on (b)(6) 2022 at 16:10 (in-dwelling time was 0.83 hours) as the bleeding was boggy the bakri /ubt (uterine balloon tamponade) placed for 0.1 hours and bleeding continued, and 2nd vacuum-induced hemorrhage control system (jada system) was placed.Initially the bleeding appeared to be controlled and the patient was observed.Anaesthesia was monitored, ordered labs and blood products were given.The patient got total of 8 units of red blood cells with initial 2 units of rbc transfusion, 2 units of platelets transfusion, 4 units of fresh frozen plasma transfusion and 2 units of cryoprecipitate transfusion for the bleeding event during the admission after vacuum-induced hemorrhage control system (jada system) removal due to abnormal uterine bleeding or pph (post-partum hemorrhage).The patient continued to bleed around the vacuum-induced hemorrhage control system (jada system) from a boggy lower uterine segment (lus).The fundus was firm, but the patient continued to bleed from the lus.An additional 800 mg of rectal misoprostol (cytotec) was placed as some misoprostol (cytotec), had come out with the fundal massaging.The decision was made to remove the vacuum-induced hemorrhage control system (jada system) and to try to place a bakri to tamponade the lower uterine segment (lus).The patient had interventional radiology for possible uterine artery embolization (uae).The bakri balloon was placed (500cc) along with 2 vaginal packs.The patient continued to bleed.Due to continued heavy bleeding, a hysterectomy was required to save her life.It was discussed with the patient's husband, that the patient would get blood products and at this point the only choice to save her life was to proceed with a hysterectomy.Supracervical hysteromy was performed with findings of postpartum uterus about 18 cm with significant lower uterine segment (lus) atony with continues bleeding and now with dic (disseminated intravascular coagulation).Normal appearing bowel, firm upper uterine segment but boggy, ballooned out lower uterine segment (lus), completely dilated cervix and normal vagina noted.The patient did not experience a device or procedure related adverse event (ae).If not treated it would result in permanent impairment of a body function or permanent damage to a body structure.It was reported that uncontrolled atony that required a hysterectomy, dic (disseminated intravascular coagulation) and icu admission.On (b)(6) 2022, the second vacuum-induced hemorrhage control system (jada system) was removed.The midwife was not involved in the procedure.The device removed and not re-inserted for any reason.There was no reason for length of resource utilization described above outside of pph management.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.On (b)(6) 2022 at 14:00 (93.83 hours after vacuum-induced hemorrhage control system (jada system) removal to discharge / 102.42 hours after admission to discharge), the subject was discharged.Upon internal review, the event device ineffective and disseminated intravascular coagulation was determined to be serious due to required intervention (devices).Medical device reporting criteria: serious injury.Fda codes: (b)(4).

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way menlo park; CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way menlo park; CA 94025
• Manufacturer Contact: 3495 edison way menlo park
• MDR Report Key: 15029322
• MDR Text Key: 295985659
• Report Number: 3017425145-2022-00117
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2 UNITS OF CRYOPRECIPITATE TRANSFUSION; 2 UNITS OF PLATELETS TRANSFUSION; 4 UNITS OF FRESH FROZEN PLASMA TRANSFUSION; 8 UNITS OF RED BLOOD CELLS; AZITHROMYCIN; CARBOPROST (HEMABATE), 1 DOSE; CEFTRIAXONE (ANCEF); INTRAVENOUS (IV) TXA (TRANEXAMIC ACID), 1 DOSE; METHYLERGOMETRINE MALEATE (METHERGINE), 1 DOSE; MISOPROSTOL (CYTOTEC); OXYTOCIN (PITOCIN); TXA (TRANEXAMIC ACID), 1 DOSE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American