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

Event Type  Injury  

Event Description

Information has been received from an investigator concerning a 31-year-old white (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 concurrent conditions included asthma and chronic hypertension reported.On (b)(6) 2022, she presented for an induction at 37.3 weeks gestational age.This was her first pregnancy.On admission (at 02:25), her hemoglobin (hgb) was 12.2 g/dl.On (b)(6) 2022, she had an emergency cesarean section (c-section) delivery and received oxytocin for induction for 32 hours.She received epidural anesthesia for delivery of an infant that weighed 3540 grams (g).The subject was noted to have postpartum hemorrhage (pph) related to uterine atony after her delivery.Placental delivery occurred at 13:52.The subject received intrapartum antibiotics (unspecified) indicated for preoperative (pre-op) c-section and for group b streptococcus.There was lower uterine segment (lus) bleeding involved in this event.Prior to vacuum-induced hemorrhage control system (jada system) insertion, this subject received tranexamic acid (txa) (2 doses), and misoprostol.The cumulative blood loss prior to the attempted vacuum-induced hemorrhage control system (jada system) insertion was noted as 2500 milliliter (ml), which was severe pph.Vacuum-induced hemorrhage control system (jada system) treatment was initiated on the same day ((b)(6) 2022 14:00) by the attending, 8 minutes after delivery of the placenta.The subject was treated with carboprost (1 dose), five units of red blood cells, and 300 units of cell salvage after the initial treatment with.It was reported that vacuum-induced hemorrhage control system (jada system) was unsuccessful in controlling pph (device ineffective) and the subject had to undergo uterine artery embolization.Due to this the hospitalization was prolonged.The subject received postpartum antibiotics gentamicin, clindamycin for vacuum-induced hemorrhage control system (jada system) use.The total blood loss for this case was 4700 ml.Vacuum-induced hemorrhage control system (jada system) was removed on (b)(6) 2022 12:00.The total in-dwelling time for vacuum-induced hemorrhage control system (jada system) was 22 hours and the total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada system) treatment was documented as 150 ml.The subject was discharged on (b)(6) 2022 18:50.Her hgb at discharge was noted at 7.1 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 device ineffective was considered to be serious as an intervention was required (uterine artery embolization).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: 14366527
• MDR Text Key: 294673487
• Report Number: 3017425145-2022-00088
• 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: 04/14/2022
• 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
• Treatment: 1. CARBOPROST (CARBOPROST) (B)(6) 2022 TO UNK; 2. RED BLOOD CELLS (RED BLOOD CELLS) (B)(6) 2022 UN
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic