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

Device Problem Suction Failure (4039)

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

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

This use of jada involved a patient with a notably adherent placenta.While the chart does not confirm an official diagnosis of placenta accreta, this placenta being adherent is notable and may related to the jada system labeling statement related to placenta accreta: precaution: the safety and effectiveness of the use of jada in patients with placenta accreta have not been evaluated.The indications for use for the jada system are as follows: the jada system is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.Treatment of placenta accreta typically involves more than conservative management, and in this case with adherent placenta and severe bleeding, this may be relevant.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 is 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.It is unclear whether the jada malfunctioned based on the information that is available at this time, but out of an abundance of caution and because we cannot rule it out 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

Patient is a (b)(6) old g2p1 two pregnancies and one previous delivery.Gestational age is (b)(6).She is not planning to breastfeed.Patient was induced as a trial of labor after cesarean (tolac) with pitocin, arom (artificial rupture of membranes) and cervical ripening balloon.She progressed to 7cm and then labor arrested.Date and time of birth: (b)(6) 2021.At 14:49 c section after failure to progress, with manual removal of sticky placenta.A thin boggy myometrium at fundus was described as worsened throughout the uterus.There was no official diagnosis of placenta accreta, but placenta noted as abnormally adherent, especially at the uterine fundus.The uterus was exteriorized and cleared of all clots and debris.Normal anatomy was noted at this time, and the hysterotomy was repaired.Due to ongoing severe bleeding after hysterotomy closure a b lynch suture was placed.This did not improve bleeding and tone, so jada was placed transvaginally, but suction did not show a good draw and evaluation showed clogging of jada where increased clot had accumulated around the suction ring.The jada was removed total ebl at time of removal estimated 3l, and a second b lynch suture was placed.Bakri was then placed and filled with 420 cc with single kerlix gauze placed as vaginal packing behind the balloon and tied to bakri tubing measure to avoid leaving packing material behind upon removal.Additional uterotonics given (methergine, hemabate x 3, rectal cytotec 800 mcg as well as tranexamic acid (txa.Bleeding flow slowed and tone improved.The second b lynch stitch pulled through the uterine tissue.There was a tear in lower uterine segment which was reapproximated with figure of 8 using 3-0 vicryl on an sh needle.The uterus replaced into abdomen, after which the abdomen was closed.While her bleeding improved, the patient remained persistently hypotensive.The patient was transferred to surgical intensive care unit (sicu) for monitoring due to risk for hemorrhagic shock, acute kidney injury, fluid overload and persistent hypotension.All these risks necessitated close hemodynamic monitoring that was not available in labor & delivery.The bakri remained in place and removed post-op day 2 (pod2).Total blood loss was documented 3.5 l.Four (4) units packed red blood cells and 1 unit fresh frozen plasma were given.Patient was discharged home.Date of admission.(b)(6) 2021.Date of discharge.(b)(6) 2021.

• 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: 11429586
• MDR Text Key: 248824722
• Report Number: 3017425145-2021-00003
• 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
• Type of Report: Initial
• Report Date: 03/06/2021

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
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 86