MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA - 1001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

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 jada treatment, the subject in this report received bakri, then a second jada was placed.The subject of this report is an (b)(6) woman, race reported as black, first pregnancy with no significant medical history reported.On (b)(6) 2021, she presented in labor at 39.7 weeks.On admission, her height was noted as 170.1 cm, weight (b)(6)., bmi 35.01, and hemoglobin (hgb) 11.4 g/dl.Her hgb at discharge was noted at 10.2 g/dl.On (b)(6) 2021, she had an augmented vaginal delivery and received oxytocin for twelve hours.She received epidural anesthesia for delivery of an infant that weighed 4400 g.The subject was noted to have postpartum hemorrhage (pph) related to retained placenta after her delivery.The crf noted that "no" there was not lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to initial jada insertion, this subject received a d&c, misoprostol, carboprost (2 doses), and txa (1 dose).The cumulative blood loss prior to jada insertion was noted as 2800 ml, which is severe pph.Jada treatment was initiated on (b)(6) 2021, 40 minutes after delivery of the placenta.The total in-dwelling time for jada was 3.25 hours and the total amount of blood collected in the canister during jada treatment was documented as unknown.The patient received five units of red blood cells, one-unit of platelets, three units of fresh frozen plasma during jada treatment.The patient was treated with bakri, then a second jada and vaginal packing after the initial jada treatment was initiated.A note on the ruby crf stated, "after d&c, jada inserted without control of bleeding; bari inserted, trickling around bakri, second jada inserted inflated to 240 ml and vag packing x1 which controlled bleeding." the total blood loss for this case was 2930 ml.The patient received intrapartum antibiotics for group b streptococcus and postpartum antibiotics (cefazolin) for jada use and manual removal of placenta.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 "yes".The crf is incomplete in the ae section at this time, requested additional information.We requested if the site retained the device or recorded the lot number for this case on 3/23/2022.This site responded that they discarded the device and do not record the lot number for jada devices.The site did not provide any further clarification or information on this case.A jada device was inserted after d&c and uterotonics failed to stop severe pph.The pph treatment continued to blood products, bakri, vaginal packing, and another jada device was inserted to stop this patient's pph.

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 treatment (bakri balloon) to preclude permanent body damage/impairment cannot be excluded.Based on the overall information currently provided in this report, there is no clear evidence that the reported circumstance (reported as "jada inserted inflated to 240 ml") with the jada system has caused or contributed to the occurrence of a potential malfunction.Of note, it was also reported that the patient received vaginal packing after 2nd jada insertion with limited details provided.This report will be amended as appropriate if additional information is received.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.", "jada preparation; fill sterile luer tapered syringe with 60 ml of sterile fluid." and "filling of cervical seal and connection of vacuum: while securely holding the seal valve and avoiding unintentional proximal or distal movement of the cervical seal away from the external cervical os, use a sterile luer tapered syringe to fill the cervical seal with 60 ml of sterile fluid.If needed, add up to another 60 ml of sterile fluid to achieve coverage of the external cervical os and create a seal for vacuum." however, out of an abundance of caution, this case will be reported 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: 14138961
• MDR Text Key: 293562806
• Report Number: 3017425145-2022-00064
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 03/22/2022
• 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: 18 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Race: Black Or African American