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

Model Number JADA - 1001

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Based on the overall information currently available for this report, a possible contributing or causal role of the jada system for the need of escalating treatment (dilation and curettage [d&c] and subsequent bakri balloon) to preclude permanent body damage/impairment cannot be excluded.With respect to the occurrence of unable to place jada (reported as "attempted jada placement but unable due to firm fundal uterine tone"), there appears to be no clear evidence at this time that the jada system caused or contributed to a potential malfunction.The reported firm fundal uterine tone may provide an alternative explanation for the event.This report will be amended as appropriate if additional information is received regarding the event.Per the jada system ifu, "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.", "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada.", "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding.", "place jada such that the intrauterine loop is located in the uterus and is oriented in the frontal plane of the body by assuring the seal valve is oriented at either 6 or 12 o'clock.Ultrasound may be used to confirm proper placement of the intrauterine loop within the uterus" and "after insertion, the intrauterine loop should be within the uterus while the cervical seal should be located within the vagina at the external cervical os." out of an abundance of caution, the company will report this case as a serious injury and malfunction mdr.

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 uterine balloon tamponade (ubt)/ bakri and dilation and curettage (d&c).The subject of this report is a (b)(6) year-old woman, race reported as white, g1p1 with no significant medical history reported.She had no previous history of abnormal postpartum uterine bleeding or postpartum hemorrhage (pph).On (b)(6) 2021, she presented for a spontaneous labor at 39.4 weeks.On admission, her height was noted as 163 cm, weight (b)(6) kg, bmi 33.12, and hemoglobin (hgb) 12.8 g/dl.Her hgb at discharge was noted at 7.2 g/dl.She had an unassisted vaginal delivery.She received epidural anesthesia for delivery of an infant that weighed 2900 g and oxytocin for five (5) hours following delivery of the infant.The subject was noted to have postpartum hemorrhage (pph) related to uterine atony after her delivery.The crf noted that "yes" 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 misoprostol, txa (1 dose), methergine (1 dose) and carboprost (1 dose).The cumulative blood loss prior to jada insertion was noted as 1200 ml.Jada treatment was initiated on (b)(6) 2022, 21 minutes after delivery of the placenta.The total in-dwelling time for jada was 20 minutes and the total amount of blood collected in the canister during jada treatment was documented as "unknown".The patient received txa (2 doses), three units of red blood cells after jada treatment was initiated.The patient received ubt/bakri for 15 hours and had a d&c after jada treatment was initiated.A note on the ruby crf stated, "jada placed in labor room with pph of 1200 cc.Bleeding noted around jade despite 120 cc in cervical cuff and suction working properly.Pt to or and jada removed, clots removed and d&c for minimal membrane and no placental fragments.Us confirms uterus empty with thin endometrial strip.Attempted jada placement but unable due to firm fundal uterine tone the jada device was extruded, therefor a bakri was successfully placed for pressure on lower uterine segment." an additional note on the ruby crf stated, "patient with chorio and sepsis required treatment in postpartum period." the total blood loss for this case was 1700 ml.The patient received intrapartum antibiotics for group b streptococcus (gbs) and postpartum antibiotic (zosyn) was administered with the indication of "clinical chorioamnionitis, d&c, jada, bakri, and sepsis".To the questions on the report asking, "did the patient experience a device or procedure related ae?" and "did the patient experience an sae, related or unrelated?", the answers were checked "no".We requested if the site retained the device or recorded the lot number for this case on 3/16/2022 and the site responded that the device was discarded, and they do not record lot numbers for jada.A good faith effort has been made to obtain this information.

• 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: 14079694
• MDR Text Key: 293365830
• Report Number: 3017425145-2022-00057
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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: 03/13/2022
• 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
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White