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 06/07/2021

Event Type  Injury  

Manufacturer Narrative

In this use of jada, care was escalated for the original diagnosis of postpartum hemorrhage, consistent with the device labeling.The user facility did not allege that the device caused or contributed to patient injury or escalation of care.It is unclear based on the information provided if the jada malfunctioned or if it functioned as expected but the bleeding continued due to other factors.Out of an abundance of caution, we are reporting this event due to the 30-day reporting deadline.If we become aware of additional information, we will supplement this report.The submission of this report is not an admission that the device caused or contributed to the reported event.

Event Description

It was reported that the patient was scheduled for induction of labor and underwent an emergency c-section for non-reassuring fetal heart tones.After the skin was closed, 500cc of blood and clots were expressed.The patient was examined and the uterus was found to be atonic.She was given a dose of hemabate and decision was made to use the jada device to control the bleeding.The jada device was inserted without complications, and set to a pressure of 90mmhg.The patient continued to have profuse bleeding from the uterus and started to have hypotension.She was given a dose of methergine, another dose of hemabate, misoprostol and txa.At this point, the decision to begin transfusion, with o negative blood until cross matched blood arrived to the unit.The massive transfusion protocol was initiated.Given the profuse amount of bleeding even with the jada device and multiple uterotonics, the decision was made to re-op.The skin was opened, followed by the subcutaneous tissue and fascia.Upon entry there was minimal amount of intraperitoneal blood.The hysterotomy was inspected and found to be hemostatic.In addition, the uterus appeared to be well contracted from above and the level of the fundus.A decision was then made to reassess from below.The lower uterine segment continued to be atonic, however was responding better to uterotonic agents.A bakri balloon was placed and filled to 350cc, which helped control and stop the bleeding from the uterus.The cervix was also inspected and a cervical laceration was ruled out.The patient was then noted to have a 2cm left sulcal laceration, likely from the time of insertion of bakri balloon given her narrow pubic arch and pelvis.The sulcal laceration was repaired.Floseal was applied to the area and 3 vaginal packs were placed.She received a total of 8uprbc, 6uffp, 1plt, 1cryo.She remained intubated due to difficulty oxygenating likely secondary to pulmonary edema.She was transferred to the sicu in stable condition.

• 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: richard ferrick ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 12451601
• MDR Text Key: 270785689
• Report Number: 3017425145-2021-00019
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 08/10/2021
• 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
• Treatment: 1 UNIT CYROPRECIPITATE; 1 UNIT PLATELETS; 6 UNITS FRESH FROZEN PLASMA; 6 UNITS PRBC; BAKRI; HEMABATE; METHERGINE; MISOPROSTOL; TXA
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 67