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 11/18/2021

Event Type  Injury  

Event Description

The patient presented with labor of twins.Antepartum bleeding due to placenta previa and the patient was moved to the operating room (or) for an emergency cesarean section (c-section).After transfer to the pacu, a uterine massage was performed on this patient and 1500 ml of blood and clots were expressed.The patient was then given methergine and the decision was made to treat with jada.The jada device was inserted and appeared to be working as expected with 100 ml evacuated and good uterine tone.The patient received blood transfusion and during that process her uterus was described as firm but blood continued to be evacuated.They noted bleeding around the jada cervical seal and the decision was made to increase the amount of fluid in the seal from 120 cc to 180cc, but the pph still continued.An additional 400 ml of blood was evacuated into the jada canister, and the decision was made to do an uterine artery embolization (uae).The patient was transferred to interventional radiology for the uae procedure.The uae was successful at controlling the pph.

Manufacturer Narrative

In this event, jada was used to control pph with a patient diagnosed with placenta previa.While jada functioned as expected, bleeding continued after treatment with jada and the decision was made to escalate to an uae.The uae was successful at controlling the pph.As we are unable to rule out the use of jada in contributing to the need to escalate care to an uae, we are reporting this an mdr in an abundance of caution.The submission of this report is not an admission that the device caused or contributed to the reported event.

• 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: 13030540
• MDR Text Key: 283775354
• Report Number: 3017425145-2021-00036
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Device Lot Number: 1060003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 79 KG