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

Model Number JADA - 1001

Device Problem Material Puncture/Hole (1504)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 01/25/2022

Event Type  Injury  

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 escalating treatment to preclude permanent body damage/impairment.The reported retained placenta may provide a more plausible alternative explanation for the uncontrolled abnormal post-partum bleeding.Per the jada system ifu "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." with respect to the reported "puncture" of the jada device, there is no clear evidence at this time that a malfunction occurred with the jada system given that the reported "punctured the jada balloon"" appears to have occurred while preforming vaginal repair.This report will be amended as appropriate if additional information is received.Per the jada system ifu "precaution: use care when suturing any lacerations to avoid puncturing or damaging the material of the cervical seal.", "prioritization of laceration repair and placement of jada for atony-related bleeding is up to the judgment of the provider."and "repair of vaginal and external genital lacerations can be performed with the jada in place." however, out of an abundance of caution, the company will report this case as a serious injury mdr.".

Event Description

Alydia health received a completed jada experience survey form that reported jada did not stop the postpartum hemorrhage (pph) and noted, "may not have been appropriate use for retained placenta 1 (one) week postpartum.Provider placed, and suture from vaginal repair punctured balloon so it was removed" in the area on the survey designated for feedback when 'jada did not stop bleeding'.This patient is described as multiparous and having delivered via cesarean section previously.Her pph started six (6) days after an augmented vaginal delivery.Prior to jada use she received one unit of blood and unknown doses of cytotec and methergine.The patient's blood loss prior to jada use was reported as 1700 ml, which is severe pph.There are additional handwritten notes on the jada experience survey that the patient in this case had retained placenta and a vaginal repair suture punctured the jada "balloon" and the device was removed.On february 10, 2022, hcp from the site responded to the request for additional information.The patient in this case presented to the er one week post-delivery, an ultrasound was performed and retained placenta tissue was noted.A difficult d&c was performed in the operating room, where it was suspected the patient had an accreta.Once it was determined all tissue was removed, the patient was noted to still be trickling blood, so a jada system was placed.After the jada was placed, the provider proceeded to repair a vaginal laceration that was previously sustained during delivery.This laceration was inadvertently opened back up during the difficult d&c.The jada was punctured by the needle used for the repair, and the jada was then removed.The patient's bleeding stopped after the laceration repair.They described this case as "complex" and it was unknown if any blood was collected in the jada canister.The site discarded this device after use, and they did not record a lot number for the jada device.A good faith effort to obtain lot number has been attempted.

Manufacturer Narrative

Correction to g3 - date reported to manufacturer is 02/01/2022.

• 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: 13652938
• MDR Text Key: 291278589
• Report Number: 3017425145-2022-00018
• 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,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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 Age: 30 YR
• Patient Sex: Female