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 Laceration(s) (1946); 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 21-year-old, non-pregnant 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 gravida and para was one.The subject had cesarean section (live birth) in past, also she was noted to have anemia during pregnancy and was taking iron tablets daily.On (b)(6) 2022 at 13:12, the subject was admitted to the hospital.During admission, the subject's body mass index (bmi) was 37.29 (units not reported) and hemoglobin (hgb) was 12.8 g/dl.On (b)(6) 2022 at 02:35, the subject delivered a singleton baby via placental (spontaneous vaginal) delivery at the gestational age of 39.9 weeks under epidural and spinal anesthesia.The baby weighed 3600 grams (g).The delivery was complicated by 60 second shoulder dystocia in the setting of tight nuchal and tight body cords, relieved by delivery of posterior arm.The subject had uterine atony and vaginal laceration (postpartum hemorrhage), which caused cumulative blood loss of 1826 milliliter (ml).Hence, the subject was given with 2 doses of carboprost, 1 dose of tranexamic acid and 1 dose of methylergometrine maleate (methergine).After delivery of baby and placenta, the oxytocin was administered for 3.33 hours; and on (b)(6) 2022 at 02:55, the vacuum-induced hemorrhage control system (jada system) was inserted at labor and delivery (l&d) by the physician.During the vacuum-induced hemorrhage control system (jada system) use, the subject was also given 4 doses of methylergometrine maleate (methergine).The vacuum-induced hemorrhage control system (jada system) could not successfully control the postpartum hemorrhage (device ineffective).On (b)(6) 2022 at 04:30, the vacuum-induced hemorrhage control system (jada system) was removed.The in-dwelling time was reported as 1.58 hours.The subject had second and third degree lacerations after delivery requiring repair, due to which vaginal packing and labial laceration repair was required.The subject was given 2 units of red blood cells due to anemia and abnormal postpartum hemorrhage.The subject also received significant phenylephrine boluses for symptomatic hypotension.The cefoxitin was given to the subject as postpartum antibiotic.The total cumulative blood loss for the event was 2009 ml.On (b)(6) 2022 at 15:45, the subject was discharged from the hospital with hgb 6.8 g/dl.The event device ineffective was considered to be serious as it required intervention.Medical device reporting criteria: serious 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.

• 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: 14366500
• MDR Text Key: 294764970
• Report Number: 3017425145-2022-00086
• 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: 04/11/2022
• 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. METHERGINE (METHYLERGOMEETRINE MALEATE); 3. OXYTOCIN (OXYTOCIN); IRON (IRON) TABLET
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic