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 Date 01/01/2022

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 jada placement and removal the patient was treated with uterine artery embolization (uae), right ureterdysis with repair of cervical and vaginal laceration, hysterectomy and right salpingo oopherectomy.The subject of this report is a (b)(6) woman, race reported as black, g1p1 with no prior history of postpartum hemorrhage (pph) and significant medical history of chronic anemia, covid-19 (current) and gestational diabetes reported.On (b)(6) 2021, she presented for an augmented vaginal delivery at 37.1 weeks.On admission, her height was noted as 63 in.Bmi 29.73, and hemoglobin (hgb) 12 g/dl.Her hgb at discharge was noted at 7.8 g/dl.On (b)(6) 2022, she had a vacuum-assisted vaginal delivery and received oxytocin after delivery of the placenta for 12 hours.She received epidural anesthesia for delivery of an infant that weighed (b)(6).The subject was noted to have postpartum hemorrhage (pph) related to uterine atony, vaginal laceration, and cervical laceration 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 jada insertion, this subject received methergine (1 dose).The cumulative blood loss prior to jada insertion was noted as 1200 ml.Jada treatment was initiated on (b)(6) 2022, 23 minutes after delivery of the placenta.The total in-dwelling time for jada was 1.5 hours and the total amount of blood collected in the canister during jada treatment was documented as 350 ml.While jada treatment was ongoing the patient received eight units of red blood cells.After jada treatment she received carboprost (1 dose), misoprostol, txa (1 dose), one unit of platelets, four units of fresh frozen plasma, and one unit of cryoprecipitate.The patient was treated with uterine artery embolization (uae not confirmed, conflicting data at this time), right ureterdysis, cervical and vaginal laceration repair, hysterectomy and right salpingo oophorectomy after the initial treatment with jada.The total blood loss for this case was 3276 ml.The patient received intraparum antibiotics for group b streptococcus (gbs) and postpartum antibiotics (ancef) for "post hysterectomy." a note on the ruby crf stated, "jada was removed once and reassessed without other obvious source of bleeding.Bleeding in jada tubing and from vagina appeared to have improved.Patient had a unresponsive episode that did not improve with sternal pub.Rabid response at bedside.Bps 50/20mtb initiated.Abdome became diffusely tender.No blood in hepatorental /splenorenal spaces or in pouch of douglas.Fundus now at u+5 and to maternal left.Area of active bleeding at fundus noted on u/s and an ara posterior to uterus that had not been there previously.Not stable for transport to vir taken to or." 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 (b)(6) 2022, and they responded that the device was discarded and that they do not record lot numbers for the jada devices.This site was also queried for data clarification on the crf, we are still pending response to this request.This report will be amended if additional information is provided.

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 interventions (repair of cervical and vaginal laceration, uterine artery embolization and hysterectomy) 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.

• 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: 14281984
• MDR Text Key: 290767665
• Report Number: 3017425145-2022-00083
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 04/07/2022
• 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): Required Intervention; Disability
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: Black Or African American