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 10/25/2021

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." the patient in this case had a jada system placed and following this placement the patient was noted to have a vaginal laceration and received uterine artery embolization and uterine packing.The patient in this case is a 30-year-old whose race was identified as "asian" and has had no previous pregnancies.She had a medical history of pre-eclampsia with severe features and gestational hypertension with this pregnancy.She presented at (b)(6) gestation for a vaginal induction of a single 2093-gram infant.Following delivery of the placenta, she was administered oxytocin for 11 hours.She experienced postpartum hemorrhage (pph) due to uterine atony and vaginal laceration.Blood loss prior to jada insertion was 1757 ml, which is severe pph.The patient received misoprostol and txa (2 doses) prior to jada insertion.The patient also received red blood cells (6 units), platelets (1 uint) and fresh frozen plasma (4 units), there was no indication of when the patient received these blood products in relation to the jada insertion.A jada system was inserted 1.97 hours after placenta delivery, the amount of blood collected in the canister during jada treatment was 850 ml, total in-dwelling time for jada documented as 7.73 hours.There is an addition note on the ruby crf that is incomplete, it states, "operative findings: uterine atony with large uterine clot, bilateral vaginal vault lacerations with left side extending up to 2 cm below level of cervix jada and vaginal packing: transfer from dublin to riverside for vir embolization, active bleeding from lus branches, near midline embolized hypertropied main uterine artery branches to uterine body and fundus embolized.After jada suction stopped, cervical seal released in vir post embolization, bleeding appeared to have significantly removed." 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".This site was contacted on 02/23/2022 regarding lot number for this case and if device was retained.This device was discarded, and they do not record lot numbers.A good faith effort has been attempted to obtain this information.

Manufacturer Narrative

Based on the overall information currently available in this report, there is no clear evidence that the jada system caused or contributed to the need for the escalating interventions (uterine artery embolization [uae] and uterine packing) to preclude permanent body damage/impairment.The assessment is impacted by the confounding factors consisting of the reported operative findings consisting of a large uterine clot and vaginal lacerations (described as "bilateral vaginal vault lacerations with left side extending up to 2 cm below level of cervix").Per the jada system ifu "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada.", "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." and "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." however, 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: 13824584
• MDR Text Key: 292746079
• Report Number: 3017425145-2022-00036
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• 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: 02/18/2022
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian