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 27-year-old, non-pregnant, white female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada system-a post-market registry" (discrepant information: age of the subject was also reported as 31-year-old).The subject's concurrent condition included gestational hypertension and gravidity 1.The subject's historical condition included spontaneous abortion.This report concerned 1 subject and 1 device.On (b)(6) 2022, at 11:44, the subject was presented in hospital for an induction at 40.6 weeks (singleton pregnancy).On admission, the subject's body mass index (bmi) was 31.25 (units not reported) and hemoglobin was 12.4 grams per deciliter (g/dl).On (b)(6) 2022, at 05:29, the subject had a vacuum-assisted vaginal delivery and received oxytocin for induction for 17 hours.The subject received epidural anesthesia for delivery of an infant that weighed 3735 grams (g).The subject was noted to had postpartum hemorrhage (pph) related to uterine atony, vaginal laceration, and cervical laceration after the delivery.It was reported that prior to vacuum-induced hemorrhage control system (jada system) insertion, the subject received 1 dose of tranexamic acid (txa), and misoprostol.The cumulative blood loss prior to the attempted vacuum-induced hemorrhage control system (jada system) insertion was noted as unknown.On (b)(6) 2022, 35 minutes after delivery of the placenta, at 06:04, the subject was initiated treatment with vacuum-induced hemorrhage control system (jada system) for pph.It was reported that the vacuum-induced hemorrhage control system (jada system) device was inserted after uterotonics failed to stop postpartum uterine bleeding.The total blood loss was reported as 1106 milliliter (ml).It was reported that the vacuum-induced hemorrhage control system (jada system) worked without issue, but the bleeding continued (device ineffective).The total in-dwelling time for vacuum-induced hemorrhage control system (jada system) was six minutes (removal at 06:10) and the total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada system) treatment was documented as 0 ml.The subject's treatment continued to laceration sutures.The subject was treated with multiple sutures after initial treatment with vacuum-induced hemorrhage control system (jada system), to achieve hemostasis for deep laceration.It was reported that second degree tac was repaired, fundus intermittently atonic, clots wiped free, left deep sulcal tac and bleeding noted.Intermittent atony also encountered.The subject received postpartum antibiotics; cefazolin (ancef) (prolongation of hospitalization).On (b)(6) 2022, at 12:01, the subject was discharged from the hospital.At discharge, the subject's hemoglobin was noted at 8.5 g/dl.It was reported that not more than one vacuum-induced hemorrhage control system (jada system) device was used, and the operator of device was attending physician.The device was not removed and not reinserted for any reason, no disseminated intravascular coagulation (dic) was diagnosed and no blood products were required during peripartum period.The suspected causes of the postpartum hemorrhage were reported as uterine atony, vaginal laceration, and cervical laceration.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.The event of device ineffective was considered to be serious as an intervention was required.

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: 14366578
• MDR Text Key: 294677103
• Report Number: 3017425145-2022-00089
• 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

• Date FDA Received: 05/11/2022
• 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: 04/15/2022
• 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
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White