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  

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

Information has been received from an investigator concerning a 35-year-old white (not hispanic or latino) female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the vacuum-induced hemorrhage control system (jada system) system: a post-market registry".This report contains one subject and one medical device.The subject's concurrent conditions included cardiovascular disease and cephalosporin allergy.The subject, gravida 1 para 1 (g1p1), had a past history of postpartum uterine bleeding that was treated with uterotonics beyond oxytocin.On (b)(6) 2022, she presented for an induced delivery at (b)(6) weeks gestational age.On admission at 07:52, her hemoglobin (hgb) was 13.7 g/dl.She had an unassisted vaginal delivery and received oxytocin prior to delivery for 14 hours.She received epidural anesthesia for delivery of an infant that weighed 4200 g (macrosomia).The subject was noted to have postpartum hemorrhage (pph) related to uterine atony and retained placenta after her delivery.It was unknown if there was lower uterine segment (lus) bleeding involved in this event.Placental delivery occurred on the same day at 20:03.The cumulative blood loss prior to the vacuum-induced hemorrhage control system (jada system) insertion was noted as 2000 ml, which was severe postpartum hemorrhage (pph).Banjo curettage with ultrasound guidance performed to ensure all membranes were removed.Prior to vacuum-induced hemorrhage control system (jada system) insertion, the subject received carboprost (also reported as carboprost(hemabate)) (2 doses), tranexamic acid (txa) (1 dose), and methergine (1 dose).Oxytocin (pitocin) was turned to 900.A postpartum hemorrhage code was called in order to facilitate a second intravenous (iv), laboratory tests, anesthesia assistance.The subject remained hemodynamically stable throughout this.At 20:20, vacuum-induced hemorrhage controlsystem (jada system) was inserted (uterine tamponade with 60cc placed in vaginal balloon and suction to 80mmhg, lot and expiration date not reported), by a resident, 17 minutes after delivery of the placenta.The total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada system) treatment was documented as 1000 ml.The subject was treated with carboprost (2 doses), txa (1 dose), misoprostol (also reported as misoprostol (cytotec)), three units of red blood cells, and one unit of fresh frozen plasma after treatment initiated with a vacuum-induced hemorrhage control system (jada system).The subject received postpartum antibiotics (gentamicin and clindamycin) for vacuum-induced hemorrhage control system (jada system) use and manual removal of placenta.Preliminary results of a rotational thromboelastometry (rotem) were normal.Stat complete blood count (cbc) was done with hematocrit of 34 (units not provided) down from 42 (units not provided) on admission.Platelets was at 113 (units not provided).Vacuum-induced hemorrhage control system (jada system) did not control postpartum bleeding (device ineffective).It was reported that the event caused prolonged hospitalization.Consult was then placed to interventional radiology for uterine artery embolization given hemodynamic stability and continued uterine bleeding with estimated blood loss (ebl) approaching 3 l.The subject intermittently required oxygen however denied any shortness of breath or chest pain and low suspicion for pulmonary edema or transfusion reaction at that time.The total blood loss for this case was 3000 ml.Vacuum-induced hemorrhage control system (jada system) was removed on (b)(6) 2022 06:45.The total in-dwelling time for vacuum-induced hemorrhage control system (jada system) was 10.42 hours.She was discharged from the hospital on (b)(6) 2022 17:41.Her hgb at discharge was noted at 8.1 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 of device ineffective was considered to be serious as an intervention was required (uterine artery embolization).Medical device reporting criteria: serious injury (b)(4).

• 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: 14375311
• MDR Text Key: 294770585
• Report Number: 3017425145-2022-00090
• 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: 05/12/2022

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: 04/27/2022
• Initial Date FDA Received: 05/12/2022
• 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: MISOPROSTOL (MISOPROSTOL) (B)(6) 2022 TO UNK; TRANEXAMIC ACID (TRANEXAMIC ACID) (B)(6) 2022 TO; CARBOPROST (CARBOPROST) (B)(6) 2022 TO UNK; FRESH FROZEN PLASMA (BLOOD PLASMA) (B)(6) 2022 T; RED BLOOD CELLS (RED BLOOD CELLS) (B)(6) 2022 TO
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White