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 12/29/2021

Event Type  Injury  

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 (uterine artery embolization) 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." out of an abundance of caution, the company will report this case as a serious injury mdr.

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 jada placement and removal the patient was treated with uterine artery embolization (uae).The subject of this report is a (b)(6) woman, race reported as white, g3p2 with no prior history of postpartum hemorrhage (pph) and no significant medical history reported.On (b)(6) 2021, she presented for an augmented vaginal delivery at 39.1 weeks.On admission, her height was noted as (b)(6), and hemoglobin (hgb) 9.1 g/dl.Her hgb at discharge was noted at 6.4 g/dl.On (b)(6) 2021, she had a c-section and received oxytocin after delivery of the placenta for ten hours.She received epidural anesthesia for delivery of an infant that weighed 3430 g.The subject was noted to have postpartum hemorrhage (pph) related to uterine atony after her delivery.The crf noted that it was "unknown" if there was lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to jada insertion, this subject received misoprostol and methergine (1 dose).The cumulative blood loss prior to the attempted jada insertion was noted as 844 ml.Jada treatment was initiated on (b)(6) 2021, 11 minutes after delivery of the placenta.The total in-dwelling time for jada was 3.28 hours and the total amount of blood collected in the canister during jada treatment was documented as 425 ml.The patient was treated with uterine artery embolization after the initial treatment with jada.The total blood loss for this case was 1569 ml.The patient received postpartum antibiotics (ancef) for "post uae." a note on the ruby crf stated, "jada inserted and bleeding continued.Jada removed and then replaced.Vaginal bleeding stopped but canister filling quickly.Decision to move to vir for uae" and "patient refused blood products." 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 discarded the device used in this case and do not record lot numbers for jada devices.A good faith effort was made to obtain this information.A jada device was inserted after uterotonics failed to stop pph.The patient's pph treatment continued to uae.As we are unable to rule out the use of jada in contributing to the need for the previous intervention, we are reporting this as a mdr in an abundance of caution.

• 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: 14251120
• MDR Text Key: 290768498
• Report Number: 3017425145-2022-00078
• 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: 04/29/2022

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: 04/01/2022
• Initial Date FDA Received: 04/29/2022
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White