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 Coagulation Disorder (1779); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Information has been received from an investigator referring to a 25-year-old female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada system-a post-market registry."the subject's concurrent conditions included platelet disorder (complex bleeding disorder), gravidity 1 and parity 1.The subject's historical conditions included pregnancy and postpartum hemorrhage (pph) (treatment: uterotonic beyond oxytocin and uterine balloon tamponade (ubt)).This report concerns 1 subject and 1 device.On (b)(6) 2022, at 22:10, the subject was presented for an induction at 38 weeks.On admission, the subject's body mass ndex (bmi) was 32.58 (units not reported), and hemoglobin (hgb) was 13.7 grams per deciliter (g/dl).On (b)(6) 2022, at 12:48, the subject had a vaginal delivery after receiving oxytocin after 11 hours.The subject received epidural anesthesia for delivery of an infant that weighed 3220 grams (g).The subject was noted to had pph related to uterine atony, retained placenta, and coagulopathy after her delivery.It was reported that it was unknown if there was lower uterine segment (lus) bleeding involved.It was also reported that prior to vacuum-induced hemorrhage control system (jada system) insertion, the subject received misoprostol and 1 dose of tranexamic acid (txa).The cumulative blood loss prior to the attempted vacuum-induced hemorrhage control system (jada system) insertion was noted as 400 milliliter (ml).On (b)(6) 2022, 12 minutes after delivery of the placenta, at 13:00, the subject was initiated treatment with vacuum-induced hemorrhage control system (jada system).The total in-dwelling time for jada was 8.08 hours (removal at 21:05), it was unknown if this was total vacuum-induced hemorrhage control system (jada system) in-dwelling time for one or both devices.The total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada system) treatment was documented as 400 ml.The subject was treated with carboprost (1 dose), misoprostol, txa (2 doses), methylergometrine maleate (methergine) (1 dose), red blood cells (rbc) (1 unit), platelets (3 units), after treatment with vacuum-induced hemorrhage control system (jada system) was initiated.It was reported that there was a recurrence of the bleeding event after initial control and vacuum-induced hemorrhage control system (jada system) removal (device ineffective).The total blood loss for this case was 2200 ml.The subject received intrapartum antibiotics for group b streptococcus and postpartum antibiotics (cefazolin) for vacuum-induced hemorrhage control system (jada system) use (prolongation of hospitalization).The subject had additional bleeding following vacuum-induced hemorrhage control system (jada system) removal.800 quantitative blood loss (qbl) was noted following vacuum-induced hemorrhage control system (jada system) removal.The uterotonics were given as listed, dilation and curettage (d and c) (with negative pathology) performed, and 2nd vacuum-induced hemorrhage control system (jada system) was placed.This delivery: delivery qbl was 400 cc; txa and rectal misoprostol (cytotec) were given; additional 400 ml blood in vacuum-induced hemorrhage control system (jada system) cannister was noted.The subject was given 2nd pit bolus, txa, misoprostol (cytotec), methergine, hemabate, platelets, 1-unit rbcs.Following 2nd vacuum-induced hemorrhage control system (jada system) removal, qbl 100 cc.The subject was put on oral (po) methergine on postpartum floor.On (b)(6) 2022, at 10:28, the subject was discharged from hospital.The subject's hgb at discharge was noted at 11.5 g/dl.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.The event of device ineffective was considered to be serious as an intervention was required.Medical device reporting criteria: serious injury.(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: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 14366465
• MDR Text Key: 294673808
• Report Number: 3017425145-2022-00085
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2022

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: 04/17/2022
• Initial Date FDA Received: 05/11/2022
• 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
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 100 KG