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 02/03/2021

Event Type  Injury  

Manufacturer Narrative

This use of jada involved a patient with a noted focal placenta accreta.The jada system labeling states: 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.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." this use of jada included a description in the medical chart of connection to vacuum being delayed.The jada system device labeling instructs the user to connect jada to the vacuum tubing after the vacuum pressure has been set and confirmed.This sequence was not followed in this case.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) g3p2 (three pregnancies, 2 deliveries).38-week vaginal delivery with spontaneous delivery of placenta.Birth (singleton) date and time: (b)(6) 2021 at 10:14am.An identified first degree vaginal laceration with delivery was repaired.There was an estimated blood loos (ebl) of 250ml with delivery.Less than one hour after delivery, the attending physician was alerted when blood loss was at 1000ml.This blood loss was post manual sweep, and after therapeutic pitocin and hemabate had been administered.An additional manual sweep removed clot in uterus and in lower uterine segment.Some "ratty tissue" was felt upon manual examination at the fundus, so a banjo curettage was performed under ultrasound guidance.More hemabate and buccal cytotec were given.Bleeding continued, so an attempt at bakri balloon placement was performed, but bakri was slipping out of patient during two separate attempts at placement.Blood loss after these attempts was noted estimated between 1500-2000ml and the patient remained hemodynamically stable.More hemabate was given."jada attempted, but became clogged as the suction to wall was delayed." it was identified upon connection that suction wasn't flowing and jada was removed.Additional manual sweeps of the uterus continued to show ongoing clot accumulation, one additional placement of a bakri balloon was performed, and it was reported that the bakri was slipping down to the lower uterine segment / cervix, but despite this, the physician decided to let the bakri remain in place with one roll of vaginal packing.This physician (who placed the bakri) also noted concern for focal accreta at anterior portion of uterus as "porous-like placental tissue".Ultrasound after the bakri was placed and filled showed ongoing clot developing in the uterine cavity behind the filled balloon, and noted that the clot was rapidly expanding (this note captured the size of the clot as approximately 3cm in diameter).By this time the patient had total blood loss of 2500 ml and had good maps (mean arterial pressures) but was tachycardic to heartrate in 140's.Mtp (mass transfusion protocol) was activated at this time as indicators were present of hemodynamic instability.Interventional radiology was consulted, and bilateral uterine artery embolization (uae) was performed, successfully, on (b)(6) 2021 at 15:46.In total, the following uterotonics were given: pitocin, hemabate x3, buccal cytotec 600mcg as well as tranexamic acid (txa) x 2.Jada was attempted but with delayed connection, suction clogged and therefore not achieved.A bakri was put in place, filled to 300 cc with 1 roll of vaginal packing.Finally, bilateral uterine artery embolization was performed.Two (2) packed red blood cell units and 1 unit fresh frozen plasma were administered.Total ebl for this delivery and pph event was 2800ml.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: 11429581
• MDR Text Key: 238333224
• Report Number: 3017425145-2021-00004
• 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: 28 YR
• Patient Weight: 82