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 Date 10/18/2021

Event Type  Injury  

Event Description

In response to the question on the ruby study case report form (crf) about whether jada controlled abnormal postpartum uterine bleeding or hemorrhage, the answer was checked "no." following the initiation of jada treatment, the patient was treated with bakri.The subject of this report is a (b)(6) woman, race reported as black, g4p2 with no prior history of postpartum hemorrhage (pph) and no significant medical history reported.On (b)(6) 2021, she presented for a scheduled cesarean section (c-section) at 29.6 weeks.On admission, her height was noted as 161.2 cm, and hemoglobin (hgb) 10.4 g/dl.Her hgb at discharge was noted at 7.8 g/dl.On (b)(6) 2021, she had a c-section and received oxytocin after delivery of the infant for two hours.She received epidural and spinal anesthesia for delivery of an infant that weighed (b)(6).The subject was noted to have postpartum hemorrhage (pph) related to uterine atony after her delivery.The crf noted that "yes" there was lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to attempted jada insertion, this subject received txa (1 dose) and methergine (1 dose).The cumulative blood loss prior to the attempted jada insertion was noted as 1800 ml, which is severe pph.Jada treatment was initiated on (b)(6) 2021, 2.2 hours after delivery of the placenta.The total in-dwelling time for jada was 5.53 hours and the total amount of blood collected in the canister during jada treatment was documented as 70 ml.The patient received carboprost (1 dose), misoprostol, and methergine (1 dose) while jada treatment was ongoing or after jada treatment.She received three units of red blood cells during jada treatment and one unit of platelets, two units of fresh frozen plasma, and one unit of cryoprecipitate were given after jada treatment.The jada was removed, and the patient was treated with bakri following the use of jada.The total blood loss for this case was 3238 ml.The patient received intrapartum antibiotics for pre-operative cesarean delivery and postpartum antibiotics (cefazolin) for jada use.To the questions on the report asking, "did the patient experience a device or procedure related ae?" and "did the patient experience an sae, related or unrelated", the answers were checked "no".We requested if the site retained the device, recorded the lot number, and additional details for this case on 04/04/2022.This site did not retain the jada device and did not record the lot number.A good faith effort has been made to obtain this information.A jada device was inserted after uterotonics failed to stop severe pph.The patient's pph treatment continued to additional uterotonics, blood product administration, and bakri.As we are unable to rule out the use of jada in contributing to the need for the previous interventions, we are reporting this as a mdr in an abundance of caution.

Manufacturer Narrative

Based on the overall information currently available for this report, a possible contributing or causal role of the jada system for the need of escalating intervention (bakri) to preclude permanent body damage/impairment cannot be excluded.Per the jada system ifu, "signs of patient 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 jada." and "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." and "the safety and effectiveness of the jada system in delivery at a gestational age < 34 weeks.With smaller uterine size, there is potential for increased risk of perforation and expulsion." out of an abundance of caution, the company will report this case as a serious injury mdr.

• 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: 14247101
• MDR Text Key: 290768955
• Report Number: 3017425145-2022-00077
• 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: 04/28/2022

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: 03/31/2022
• Initial Date FDA Received: 04/28/2022
• 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 Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: Black Or African American