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 Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 01/22/2022

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 a uterine artery embolization.The subject of this report is a (b)(6) woman, g2p2 with gestational diabetes and jehovah's witness who refuses blood products, noted as significant medical history.The subject had no previous abnormal postpartum uterine bleeding or pph.On (b)(6), 2022, she presented for a scheduled repeat cesarean section (c-section) at 40 weeks and received oxytocin for four and one half (4.5) hours following delivery of the placenta.On admission, her height was noted as 60 inches, weight (b)(6) pounds, bmi 43.26 and hemoglobin (hgb) 10.8 g/dl.Her hgb at discharge was noted at 9.6 g/dl.She received spinal anesthesia and delivered a 3710 g infant.The subject was noted to have postpartum hemorrhage related to uterine atony after her delivery.The crf noted that "unknown" if there was lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to jada insertion, this subject received carboprost (1 dose), misoprostol, txa (1 dose), and methergine (1 dose).The cumulative blood loss prior to jada insertion was severe, noted as 1500 ml.Jada was noted to be inserted on (b)(6) 2022, 4.27 hours after placenta delivery and the in-dwelling time of jada was noted as 12.72 hours.The total amount of blood collected in the jada canister was noted as 200 ml and estimated blood loss for this event was reported as 1700 ml.After jada treatment was initiated, this patient received 6 doses of methergine, one dose of txa.Cell saver was used, and 70 ml of blood was transfused back into the patient.She received pre-op antibiotics for c-section.She was administered postpartum antibiotics (invanz) for endometritis.Additional information that was provided within the ruby crf regarding jada removal stated, "given persistent bleeding and episode of hypotension, the decision was made to proceed with the uae.".

Manufacturer Narrative

Lot number is not currently available for this event.Request sent to site for lot number, no response to this request to date.A good faith effort to obtain lot number has been attempted.This report will be amended if we receive additional information regarding this event.Per the jada system ifu "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." and "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." based on the overall information currently available in this report, a possible contributing or causal role of the jada system to the need for escalating treatment (uterine artery embolization) and the treatment of antibiotics for endometritis to preclude permanent body damage/impairment cannot be excluded.Hence the company will report this case 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: 13551936
• MDR Text Key: 289186242
• Report Number: 3017425145-2022-00009
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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: 01/18/2022
• 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; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 93 KG