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 36-year-old adult white (ethnic group: 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 uterine atony.The subject's body mass index (bmi) was 43.16 (units not provided).Her historical condition included first pregnancy with twin pregnancy.On 18-jun-2021 at 09:34, the subject got admitted to hospital for delivery at 37.9 gestational age (unit not provided).On admission the subject's hemoglobin (hgb) was found to be 13.4 (units not provided).The subject was scheduled for c-section (caesarean section) for labor of twin pregnancy.Oxytocin was used at postpartum haemorrhage (pph) for 4 hours.She received spinal anesthesia for delivery and the subject delivered twin babies at 12:24 on 18-jun-2021 (after 2.83 hours) with baby a birthweight: 3080 grams and baby b birthweight: 2720 grams.It was reported that prior vacuum-induced hemorrhage control system (jada system) insertion, the subject received 1 dose of carboprost, misoprostol, 1 dose of methylergometrine maleate (methergine) and 1 dose of txa (tranexamic acid).It was unknown whether lower uterine segment (lus) bleeding was involved, and a cumulative blood loss was 1900 (unit unspecified) was noted after delivery.It was reported that none were given at the time or after vacuum-induced hemorrhage control system (jada system) use.Post-partum antibiotics of gentamycin and clindamycin for manual sweeps.On 18-jun-2021 (the same day) at 14:05, the subject had vacuum-induced hemorrhage control system (jada system) insertion at post-anaesthesia care unit (pacu) by the 3rd year post graduation (pg) resident doctor, after 1.68 hours of placental delivery to control pph (post-partum hemorrhage) and the subject had total cumulative blood loss for the event was 2200 (unit unspecified).It was 2-5 minutes, the time from vacuum connection to control of abnormal bleeding with vacuum-induced hemorrhage control system (jada system).Total amount of blood collected in canister during vacuum-induced hemorrhage control system (jada system) treatment was 100 (unit unspecified).The subject did not get a transfusion for this bleeding event during the admission.There was no uterine compression suture used for this bleeding event.The vacuum was not reapplied during/after any verification step for additional bleeding.There was no recurrence of the bleeding event after initial control and vacuum-induced hemorrhage control system (jada system) removal.Vacuum-induced hemorrhage control system (jada system) successful was in controlling abnormal postpartum uterine bleeding or pph (post-partum hemorrhage).On 18-jun-2021 at 17:17 (in-dwelling time was 3.20 hours), the vacuum-induced hemorrhage control system (jada system) was removed.The midwife was not involved in the procedure.The device removed and not re-inserted for any reason.There was no reason for length of resource utilization described above outside of pph management.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.On 21-jun-2022, the subject was diagnosed with post-partum pre-eclampsia with severe features on post-operative day (pod) 4 (pre-eclampsia).On 24-jun-2022, the subject was discharged and at discharge hgb was 10.6 (no units provided).The subject was discharge on nifedipine (procardia) and enrolled in vivify.The outcome of pre-eclampsia was reported as not recovered.The investigator considered pre-eclampsia to be not related to vacuum-induced hemorrhage control system (jada system).The investigator considered the event pre-eclampsia serious medically significant.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.).

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: 15029321
• MDR Text Key: 295985817
• Report Number: 3017425145-2022-00119
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2022

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: 09/24/2021
• Initial Date FDA Received: 07/15/2022
• 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: CLINDAMYCIN (CLINDAMYCIN); GENTAMYCIN [GENTAMICIN] (GENTAMYCIN [GENTAMICIN]); NIFEDIPINE (PROCARDIA)
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White