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 Disseminated Intravascular Coagulation (DIC) (1813); Hypovolemic Shock (1917)

Event Type  Injury  

Event Description

Information has been received from an investigator concerning a 30-year-old white 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 current condition includes premature separation of placenta, uterine atony, coagulopathy and antepartum haemorrhage.This was the subject's first pregnancy (singleton, gravida 1 and parity 1).The weight of the baby was reported as 2890 grams.Emergency cesarean was the delivery method of the current pregnancy, the gestational age at delivery was 35.3 (units unknown).The delivery was induced in 0.1 hours, and general anesthesia was used.The oxytocin and misoprostol were given prior to use of vacuum-induced hemorrhage control system (jada system).Lower uterine segment (lus) bleeding was not involved.The estimated blood loss (ebl/qbl) prior to vacuum-induced hemorrhage control system (jada system) use was 3,000 (units unknown).On (b)(6) 2021, the subject was started on vacuum-induced hemorrhage control system (jada system) (total duration of use was 15 hours) for uterine atony, placental abruption and coagulopathy.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.On (b)(6) 2021, the subject experienced hypovolaemic shock and disseminated intravascular coagulation (dic).The subject was admitted to intensive care unit (icu) admission due to dic/coagulopathy following postpartum hemorrhage (pph) for 3 days.The vacuum-induced hemorrhage control system (jada system) stopped the bleeding.A uterine compression suture was not used for this bleeding event.There were no escalating treatments required after vacuum-induced hemorrhage control system (jada system) use to control the abnormal postpartum uterine bleeding or hemorrhage.The bleeding did not continue or re-start during the vacuum-induced hemorrhage control system (jada system) verification step.100 (units unknown) blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.Estimated total blood loss at delivery was 3100 milliliter (ml).On (b)(6) 2021, the hemoglobin (hgb) at admission was 10.8 (no units provided) and on (b)(6) 2021, at discharge, it was 8.4 (no units provided).It was also reported that the dic was diagnosed prior to vacuum-induced hemorrhage control system (jada system).4 units of packet red blood cells (prbcs), 1 unit of platelets, 2 units of fresh frozen plasma (ffp), 2 units of cryoprecipitate were required during peripartum period.The suspected cause of the postpartum hemorrhage were uterine atony, placental abruption, and coagulopathy (including dic, inherited coagulation defects, or idiopathic from medications).On (b)(6) 2021, the subject was hospitalized and on (b)(6) 2021, the subject was discharged.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The outcome of hypovolaemic shock and disseminated intravascular coagulation was reported as recovered.The investigator considered hypovolaemic shock and disseminated intravascular coagulation to be life threatening.The investigator assessed the events hypovolemic shock (severe) and disseminated intravascular coagulation (severe) to be not related to vacuum-induced hemorrhage control system (jada system) or procedure.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.

Event Description

Information has been received from an investigator concerning a 30-year-old white 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 current condition includes premature separation of placenta, uterine atony, coagulopathy and antepartum haemorrhage.This was the subject's first pregnancy (singleton, gravida 1 and parity 1).The weight of the baby was reported as 2890 grams.Emergency cesarean was the delivery method of the current pregnancy, the gestational age at delivery was 35.3 (units unknown).The delivery was induced in 0.1 hours, and general anesthesia was used.The oxytocin and misoprostol were given prior to use of vacuum-induced hemorrhage control system (jada system).Lower uterine segment (lus) bleeding was not involved.The estimated blood loss (ebl/qbl) prior to vacuum-induced hemorrhage control system (jada system) use was 3,000 (units unknown).On (b)(6) 2021, the subject was started on vacuum-induced hemorrhage control system (jada system) (total duration of use was 15 hours) for uterine atony, placental abruption and coagulopathy.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.On (b)(6) 202, the subject experienced hypovolaemic shock.The subject was admitted to intensive care unit (icu) admission due to dic/coagulopathy following postpartum hemorrhage (pph) for 3 days.The vacuum-induced hemorrhage control system (jada system) stopped the bleeding.A uterine compression suture was not used for this bleeding event.There were no escalating treatments required after vacuum-induced hemorrhage control system (jada system) use to control the abnormal postpartum uterine bleeding or hemorrhage.The bleeding did not continue or re-start during the vacuum-induced hemorrhage control system (jada system) verification step.100 (units unknown) blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.Estimated total blood loss at delivery was 3100 milliliter (ml).On (b)(6) 2021, the hemoglobin (hgb) at admission was 10.8 (no units provided) and on (b)(6) 2021, at discharge, it was 8.4 (no units provided).It was also reported that the dic was diagnosed prior to vacuum-induced hemorrhage control system (jada system).4 units of packet red blood cells (prbcs), 1 unit of platelets, 2 units of fresh frozen plasma (ffp), 2 units of cryoprecipitate were required during peripartum period.The suspected cause of the postpartum hemorrhage were uterine atony, placental abruption, and coagulopathy (including dic, inherited coagulation defects, or idiopathic from medications).On (b)(6) 2021, the subject was hospitalized and on (b)(6) 2021, the subject was discharged.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The outcome of hypovolaemic shock was reported as recovered.The investigator considered hypovolaemic shock to be life threatening.The investigator assessed the event hypovolemic shock (severe) to be not related to vacuum-induced hemorrhage control system (jada system) or procedure.Per investigator, hypovolemic shock was the main sae that led to disseminated intravascular coagulation (severe).Hence the event of disseminated intravascular coagulation (severe) was deleted from the case.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.) fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.).

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 park
• MDR Report Key: 15019856
• MDR Text Key: 295955101
• Report Number: 3017425145-2022-00113
• 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,Followup
• Report Date: 08/11/2022

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• 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.; OXYTOCIN.; OXYTOCIN.
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White