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

Model Number JADA-1001

Device Problem Suction Problem (2170)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

It is unclear why the jada device was not able to provide suction in this case.It is unclear whether the jada malfunctioned or if there was a uterine anomaly that led to both the jada and bakri devices being unable to control the bleeding.Out of an abundance of caution and because we cannot rule out a device malfunction at this time, 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 jada placement was attempted in a patient after uterotonics failed and the patient had lost 2300 cc of blood.Jada was inserted but the attending staff was not able to achieve suction with jada and did not see blood flowing through the jada tubing.The site was not able to recall if there was an effort to remove blood clots or products of conception (poc) prior to insertion of the device or the amount of fluid instilled into the cervical seal.The jada device was removed and cleared of clots that were seen to be blocking the pores.Jada was replaced but the staff was still not able to achieve suction with jada.Correct placement was verified with ultrasound and both the vacuum and the canister were checked and were working correctly.The jada was removed.Next, there was an attempt to place a bakri device but the staff was unable to inflate the bakri.The physician believed there was an issue with the patient's anatomy and they transferred treatment to interventional radiology (ir).The bleeding was successfully controlled by ir.

• 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: 12351810
• MDR Text Key: 267628600
• Report Number: 3017425145-2021-00018
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 07/22/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 79