MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Type  Injury  

Event Description

To the questions on the report asking, "did the subject experience a device or procedure related adverse event (ae)?" and "did the subject experience an serious adverse event (sae), related or unrelated?", the answers were checked "yes".The case report form (crf) contains a statement "postpartum tachycardia following vacuum-induced hemorrhage control system (jada system) removal".The subject of this report was a 31-year-old woman, race reported as american indian or alaska native, first pregnancy with significant medical history of gestational hypertension, anemia, and obesity reported.On (b)(6) 2022, she presented for induction at 41.1 weeks.On admission, her height was noted as 160 centimeters (cm), weight 102 kilograms (kg.), body mass index (bmi) 39.84 (no units provided), and hemoglobin (hgb) 10.6 gram per deciliter (g/dl).Her hgb at discharge was noted at 10 g/dl.On (b)(6) 2022, she had a cesarean section delivery after receiving oxytocin for induction for twenty-one hours.She received epidural anesthesia for delivery of an infant that weighed 4010 grams (macrosomia).The subject was noted to have postpartum hemorrhage (pph) related to uterine atony after her delivery.The crf noted that "unknown" there was lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to initial vacuum-induced hemorrhage control system (jada system) insertion, this subject received uterine compression sutures, misoprostol, carboprost (2 doses), methergine (1 dose), and tranexamic acid (txa) (2 doses).The cumulative blood loss prior to vacuum-induced hemorrhage control system (jada system) insertion was noted as 1700 milliliters (ml), which is severe pph.The vacuum-induced hemorrhage control system (jada system) treatment was initiated on (b)(6) 2022, 1.18 hours after delivery of the placenta.The total in-dwelling time for vacuum-induced hemorrhage control system (jada system) was 7.67 hours and the total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada system) treatment was documented as 100 milliliters (ml).The vacuum-induced hemorrhage control system (jada system) was noted as successfully stopping the subjects pph.The patient received four units of red blood cells after vacuum-induced hemorrhage control system (jada system) treatment.The total blood loss for this case was 1800 milliliters (ml).The subject received intrapartum antibiotics preoperatively for cesarean section and postpartum antibiotics (cefazolin sodium (ancef)) for vacuum-induced hemorrhage control system (jada system) use.On (b)(6) 2022, after vacuum-induced hemorrhage control system (jada system) device was inserted and successfully treated pph that uterine compression sutures and uterotonics failed to stop, the subject experienced an sae described as "postpartum tachycardia." this sae was reported as being treated with blood transfusion and resolution was achieved on (b)(6) 2022.The site described this as an unanticipated sae, that was possibly related to the vacuum-induced hemorrhage control system (jada system) device or procedure, and moderate in severity.(b)(4).

Manufacturer Narrative

Additional manufacturer narrative/ comments: based on the overall information currently provided in this report, there is no clear evidence that the vacuum-induced hemorrhage control system (jada system) has caused or contributed to the occurrence of a potential malfunction and/or serious injury.The reported tachycardia (reported as "postpartum tachycardia") is confounded by the subject's underlying severe post-partum hemorrhage with a cumulative blood loss of 1700 ml noted prior to vacuum-induced hemorrhage control system (jada system) insertion.Per the vacuum-induced hemorrhage control system (jada system) ifu, "signs of subject deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding."evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using vacuum-induced hemorrhage control system (jada system)." and "vacuum-induced hemorrhage control system (jada system) is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." out of an abundance of caution, the company will report this case as a serious injury medical device report (mdr).Follow-up information from the site indicated that no serious adverse events were actually involved in previously reported experience(s).Therefore, case # (b)(4) is being deleted from our files on vacuum-induced hemorrhage control system (jada system).

• 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: 15000091
• MDR Text Key: 295781364
• Report Number: 3017425145-2022-00108
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA1001
• Device Catalogue Number: JADA1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARBOPROST; CEFAZOLIN SODIUM (ANCEF); INTRAPARTUM ANTIBIOTICS; METHERGINE; MISOPROSTOL; POSTPARTUM ANTIBIOTICS; TRANEXAMIC ACID (TXA); UTERINE COMPRESSION SUTURES; UTEROTONICS
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: American Indian Or Alaskan Native