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

Model Number JADA-1001

Device Problem Decrease in Suction (1146)

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

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

In this jada set up, the level of vacuum pressure administered (100 mmhg) and the amount of sterile fluid used to fill the seal (180 cc) were outside of the ranges in the jada system labeling.The labeling statements on vacuum setting and seal fill are as follows: "while securely holding the seal valve and avoiding unintentional proximal or distal movement of the cervical seal away from the external cervical os, use a sterile luer tapered syringe to fill the cervical seal with 60 ml of sterile fluid.If needed, add up to another 60 ml of sterile fluid to achieve coverage of the external cervical os and create a seal for vacuum (see figure 3)." "set the vacuum source to 80 mm hg +/- 10 mm hg while occluding the end of the tubing (80 mm hg = 1.5 psi = 10.7 kpa = 3.2 in hg = 106.7 mbar) (see figure 4)." in this use of jada, care was escalated for the original diagnosis of postpartum hemorrhage, consistent with the device labeling.The device labeling statement related to reassessment and escalation of care are as follows: "warning: 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."only "suspected clots" were noted in the medical record of this case without any documentation of observation of actual clot.

Event Description

Patient is a (b)(6)-year-old g7p4 (7 pregnancies and 4 deliveries) who delivered at 38 weeks and 1 day.Patient presented for induction of labor.Patient was induced with cytotec, cervical ripening balloon, arom (artificial rupture of membranes) and pitocin.Patient delivered vaginally after three pushes on (b)(6) 2020 at 8:03am.Pitocin was given after delivery of infant for active management of the third stage of labor.A "gush of bleeding 10 minutes after delivery with retained placenta, coming out in pieces" was identified.Manual removal of placenta was performed with banjo curettage performed under ultrasound guidance.Patient noted to have brisk bleeding with significant atony.Pitocin, methergine (felt safe even though hx of hypertension), hemabate (felt to be safe despite hx of remote asthma in the setting of brisk and significant pph) used prior to jada.Patient was at 1000ml total estimated blood loss (ebl) when jada called for, had emesis and was somnolent, with bp 50s/20s.Patient at this time became minimally responsive but had a good pulse and was saturated to mid-90's.With sternal rub, patient became more aroused and could answer questions.Emergency call for blood and cross match was made at this time.Jada placed at ebl of 1300 ml ebl.120 cc used to fill seal initially.Set suction to 100 mmhg.Foley catheter was also placed to ensure adequate drain of bladder.Some oozing continued around seal, so additional 60 cc added to seal (total now confirmed in record at 180 cc).A dose of hemabate and a dose of tranexamic acid (txa) were given after jada placement.One (1) unit of blood was given in addition to fluids.About 200ml blood was noted in the canister, and total ebl thought to be 1800 ml considering oozing around the seal and the amount in canister.Abnormal bleeding was controlled and was not increasing in canister.Patient's blood pressure had improved to 120's/70's, heartrate improved and only patient complaint noted was a headache.Jada in place about 1 hour after control established.When physician began to consider removal of jada, they found an additional 260 ml blood had come out around the jada seal, and 300 cc in canister.The total ebl at this time noted as 2400 ml, after which they gave additional txa, methergine and hemabate.The sterile tubing connecting jada to an in-line canister and to wall suction was replaced when it was recognized jada had "minimal suction" as a trouble-shooting measure.However, "minimal suction" and "suspect clots in device" were noted."jada device removed as suspect clots preventing suction from working." at this time the physician decided to take the patient to interventional radiology (ir) for uterine artery embolization (uae).At ir, bilateral uae for pph was performed.In total, three (3) units packed red blood cells and 1 unit fresh frozen plasma were given and the patient had a reaction thought be due to her blood transfusion inclusive of transient hypoxia, hypotensive episode (lasting 20 minutes) and significant urticaria rash throughout her torso that resolved within 24 hours.This reaction was also noted as possibly exacerbated by significant narcotic use (fentanyl) during her uae procedure.Date of admission: (b)(6) 2020.Date of discharge: (b)(6) 2020.

Manufacturer Narrative

A correction to revise the labeling for the jada system will be conducted as described in the attachments.Please see "attachment 1 - alydia health jada system all order as of (b)(6) 2022" and "attachment 2 - alydia health device correction information.".

Manufacturer Narrative

Please find attached the draft template communication to be sent to consignees regarding the jada label update, once finalized.

Manufacturer Narrative

In follow up to our previous submissions, please see the attached: information update (attachment 1_mdr 3017425145-2021-00001_03mar2022.Pdf) and distribution spreadsheet (alydia distribution_lot_expiry_list_3017425145-2022-00001.Pdf).

• 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: 11429585
• MDR Text Key: 240653520
• Report Number: 3017425145-2021-00001
• Device Sequence Number: 1
• Product Code: OQY
• 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
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• 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: 02/04/2021
• 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
• Treatment: 1 UNIT FRESH FROZEN PLASMA; 3 UNITS PACKED RED BLOOD CELLS; BANJO CURETTAGE; HEMABATE; METHERGINE; PITOCIN; TRANEXAMIC ACID; UTERINE ARTERY EMBOLIZATION
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 100 KG