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

Model Number JADA-1001

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.

Event Description

Initial information has been received from an investigator concerning a 36-year-old black or african american female (not hispanic or latino) 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 concurrent conditions included chronic anemia (diagnosis pre-pregnancy), pre-eclampsia with severe features (current pregnancy), gravidity 1 and parity 1.Her historical condition included vaginal delivery (1 live birth).The subject did not experience abnormal postpartum uterine bleeding at previous delivery.Concomitant medications were not reported.On (b)(6) 2022 17:51, the subject was admitted to the hospital at a gestational age of 36 weeks.On admission, the subject's body mass index (bmi) was 32.03 (units not reported) and hemoglobin (hgb) was 11.5 (units not reported).Labor was induced with oxytocin for 20 hours and on (b)(6) 2022, the subject had a vaginal delivery.The subject received epidural anesthesia for delivery of an infant weighing 1820 grams.The subject was noted to have postpartum hemorrhage (pph) related to uterine atony.It was reported that prior to vacuum-induced hemorrhage control system (jada system) insertion, the subject received 1 dose of carboprost, 2 doses of tranexamic acid (txa), and misoprostol.At 22:02, placental delivery occurred.On (b)(6) 2022 (also reported as (b)(6) 2022) at 06:30, vacuum-induced hemorrhage control system (jada system) (serial #, lot# and expiration date were not reported) was inserted by obstetrics (ob) hospitalist (covering for attending ob doctor who was in a delivery) for abnormal postpartum uterine bleeding or pph.The cumulative blood loss (quantitative blood loss (qbl)) at the time of vacuum-induced hemorrhage control system (jada system) insertion was noted as 1400 (units not reported).Time from vacuum connection to control of abnormal bleeding with vacuum-induced hemorrhage control system (jada system) was 0-1 min.It was successful in controlling pph.On the same day (also reported as (b)(6) 2022) at 09:00, vacuum-induced hemorrhage control system (jada system) was removed.Total duration of use (in-dwelling time) was 2.5 hours.Total cumulative blood loss (qbl) for the event was 1591 (units not reported).Total amount of blood collected in canister during vacuum-induced hemorrhage control system (jada system) treatment was 50 (units not reported).On (b)(6) 2022, the subject experienced postpartum endometritis (endometritis decidual) (mild).She received antibiotic therapy and the event resolved on (b)(6) 2022.She also received ampicillin sodium (+) sulbactam sodium (unasyn) for the event.As per reporter, the event did not prolong hospitalization as subject needed additional time for blood pressure management to titrate new antihypertensive medications.It was reported that it required several days to manage preeclampsia with severe features, blood pressure regulation and medication regulation, pph management and treatment of postpartum (pp) endometritis.The subject was discharged from the hospital on (b)(6) 2022 19:21.Hgb at discharge was 10 (units not reported).The vacuum-induced hemorrhage control system (jada system) admission to discharge time was 193.50 (units not reported).It was reported that the event endometritis decidual (mild) was unanticipated.The investigator assessed the event to be possibly related to vacuum-induced hemorrhage control system (jada system) and procedure.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The investigator considered the event endometritis decidual (mild) serious due to required intervention (devices).Medical device reporting criteria: serious injury.(b)(4).

• Brand Name: ALYDIA HEALTH
• 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; 94025
• Manufacturer Contact: 3495 edison way menlo park
• MDR Report Key: 15029325
• MDR Text Key: 295991846
• Report Number: 3017425145-2022-00118
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2022
• Initial Date FDA Received: 07/15/2022
• 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: 1 DOSE OF CARBOPROST,; AMPICILLIN SODIUM (+) SULBACTAM SODIUM (UNASYN); DOSES OF TRANEXAMIC ACID (TXA); MISOPROSTOL; OXYTOCIN
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American