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 Bacterial Infection (1735); Sepsis (2067)

Event Type  Injury  

Event Description

Initial information has been received from an investigator referring to a 30-year-old asian (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 pre-eclampsia with severe features (current pregnancy).On (b)(6) 2022 11:44, the subject was admitted to the hospital at a gestational age of 36 weeks (first pregnancy).On admission, the subject's body mass index (bmi) was 31.30 (units not reported) and hemoglobin (hgb) was 14.7 (units not reported).Labor was augmented on (b)(6) 2022, the subject had an emergency cesarean section.She received general anesthesia for delivery of an infant weighing 2101 grams.The subject was noted to have postpartum hemorrhage (pph) related to coagulopathy, disseminated intravascular coagulation (dic).It was reported that prior to vacuum-induced hemorrhage control system (jada system) insertion, the subject received 1 dose of methylergometrine maleate (methergine).She also received 1 unit of cryoprecipitate and 1 unit of fresh frozen plasma for dic.At 01:13, placental delivery occurred.At 02:11, vacuum-induced hemorrhage control system (jada system) (serial #, lot# and expiration date were not reported) was inserted by the attending for abnormal postpartum uterine bleeding or pph.During vacuum-induced hemorrhage control system (jada system) use, the subject was transfused with red blood cells 2 units for dic.Blood loss less than 1500 milliliter (approximately) was noted.Vacuum-induced hemorrhage control system (jada system) was successful in controlling pph.At 04:47, vacuum-induced hemorrhage control system (jada system) was removed.Total duration of use (in-dwelling time) was 2.6 (units not reported).Total cumulative blood loss (quantitative blood loss (qbl)) for the event was 1052 (units not reported).She was moved to high risk obstetrics at 05:19.On (b)(6) 2022, the subject developed worsening abdominal pain and maximum temperature (tmax) of 100.3 (units not reported).Computed tomography of the abdomen and pelvis (ctap) showed increased fluid in abdominal subcutaneous (subq) tissue without clear seroma or hematoma.Subject was amenable to drainage on 3.30 cultures which was positive (+) for escherichia coli (e.Coli) (e.Coli bacteremia) (moderate).The subject was moved to the intensive care unit on (b)(6) 2022 18:20.Intravenous (iv) antibiotics were initiated, and she was put on a 10 day course of ertapenem.The subject was also treated with cetirizine hydrochloride (ancet), piperacillin sodium (+) tazobactam sodium (zosyn), azithromycin for sepsis.She refused "bedside labor and delivery (l&d)".Action taken for the event was reported as medical procedures.As per infectious disease, source thought to be retroperitoneal (rh) postoperative hematoma while thrombocytopenic or coagulopathy that became super infected with subject's own flora.The subject was moved to surgical unit on (b)(6) 2022 18:12.The subject recovered from e.Coli bacteremia (moderate) on the same day.She was discharged for home on stable condition on (b)(6) 2022 17:35 with long term iv access to continue iv ertapenem.Hgb at discharge was 7.4 (units not reported).The reason for length of resource utilization was reported as 24 hour postpartum magnesium drip, preeclampsia, hemolysis, elevated liver enzymes, and low platelets (hellp), dic, sepsis with extended spectrum beta-lactamase (esbl), e.Coli bacteremia, acute kidney injury and hyperkalemia.The subject also had subcutaneous swelling, incisional drainage, "noted 3.28" (unspecified) with elevated white blood cells (wbc) and sepsis.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.It was reported that the event e.Coli bacteremia (moderate) was unanticipated.The investigator assessed the event to be not related to vacuum-induced hemorrhage control system (jada system) or procedure.The investigator considered the e.Coli bacteremia (moderate) to be life threatening and medically significant.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: 3495 edison way; menlo parka
• MDR Report Key: 15019852
• MDR Text Key: 295955359
• Report Number: 3017425145-2022-00115
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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
• Date Manufacturer Received: 04/18/2022
• 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: AZITHROMYCIN; CETIRIZINE HYDROCHLORIDE (ANCET),; CRYOPRECIPITATE; ERTAPENEM; FRESH FROZEN PLASMA; INTRAVENOUS (IV) ANTIBIOTICS; MAGNESIUM DRIP; METHYLERGOMETRINE MALEATE (METHERGINE); PIPERACILLIN SODIUM (+) TAZOBACTAM SODIUM (ZOSYN),; RED BLOOD CELLS (RED BLOOD CELLS); SPECTRUM BETA-LACTAMASE (ESBL)
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian