MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/06/2023

Event Type  Injury  

Event Description

The patient was still bleeding [device ineffective].Endometritis [endometritis].I troubleshooted twice but i don¿t think it actual got expelled [device placement issue].Case narrative: this initial spontaneous report originating from the united states was received from a physician via clinical account specialist (cas), referring to a 19-year-old non-pregnant female patient.The patient's current condition included gestational hypertension, gravida 1 and para 0 (nullipara) (reported as g1, p0) (also reported as p1, g0; discrepancy).The patient¿s medical history included singleton pregnancy and she had spinal anesthesia for caesarean section (not induced) for placental abruption at 40 weeks and 4 days of gestation.There were no invasive placenta, disseminated intravascular coagulation (dic), or hyperglycemia.She had uterine atony (lower segment and fundus) in the operating room (or) (considered as hospitalization).The total blood loss at delivery was 400 ml.She received 3 doses of carboprost trometamol (hemabate), methylergometrine maleate (methergine) and oxytocin (pitocin), as well as a b-lynch suture and tranexamic acid (txa) however, she continued to bleed.The estimated blood loss prior to vacuum-induced hemorrhage control system (jada system) use was 1500 ml (discrepancy; also reported as 400 ml).Her past drugs and allergies were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiry date were not reported) intravaginally for postpartum hemorrhage, by the physician.Reportedly, the device came with a green carton, but the reporter was not sure, and no damage was noted on the carton.It was reporter¿s second experience with the vacuum-induced hemorrhage control system (jada system) (received training in early april 2023).It was reported that the device kept popping out.The two times that the tubing seemed to get longer; it looked like the device was coming down in the vagina instead of near the fundus.There was never bleeding around the seal though and it was just through the tubing.Reportedly, foley catheter was used in the vicinity of the vagina.The physician reported 120 ml of sterile saline was placed in the seal, suction was troubleshooted, it was initially at 120 mmhg and reduced to 100 mmhg.After 45 minutes in the post-anesthesia care unit (pacu), the patient was still bleeding (device ineffective).The device was removed and then reinserted.The device was visualized by ultrasound performed to check its positioning and the uterus was still in atony.The reporter also stated that the tubing was initially not taped to inner thigh after insertion because they were still intraoperative but then the physician did tape it to her leg before they moved the patient from the or to pacu and in pacu, it looked like it was in place externally and the physician confirmed by ultrasound and got 500 ml in 35 minutes.A total of 1600 ml out through the vacuum-induced hemorrhage control system (jada system) and then in pacu after b-lynch suture was closed up another 500 ml of blood was collected in the canister (also reported as 400 ml; discrepancy).On the same day at 6:45 am, the device was removed, patient received carboprost trometamol (hemabate), methylergometrine maleate (methergine), oxytocin (pitocin) and tranexamic acid (txa) (also reported as "2 other uterine tonics; exact medications unknown)"; discrepancy) and bleeding stopped.The physician also reported that after the device was removed, another ultrasound was performed (result and purpose not reported) and at the time of report, the physician was treating the patient for endometritis (onset date: (b)(6) 2023) and may be that was what was going on.When the physician took the device out, she had a lot less pain and continued that with the next fundal checks.The patient has had minimal bleeding since removal of the device.The device was troubleshooted twice, but he didn¿t think it actual got expelled (device placement issue).The suspected cause of the postpartum hemorrhage was uterine atony.More than one device was not used.Patient¿s admission to intensive care unit (icu) was not required.On an unknown date in (b)(6) 2023, the hospitalization was prolonged due to the events of endometritis and device ineffective.The patient was recovering, getting blood products; 4 units of blood and an unknown amount of fresh frozen plasma (ffp).No injury to the uterus occurred.The patient¿s placenta was sent to pathology.The physician was disappointed so far with how the vacuum-induced hemorrhage control system (jada system) worked.The vacuum-induced hemorrhage control system (jada system) was not available for evaluation as it was discarded.Upon internal review, the events of device ineffective and endometritis were considered as serious as they required intervention.Upon internal review, the event of endometritis was determined as medically significant.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 17085502
• MDR Text Key: 316881259
• Report Number: 3002806821-2023-00070
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMABATE (CARBOPROST TROMETAMOL).; METHERGINE (METHYLERGOMETRINE MALEATE).; PITOCIN [OXYTOCIN] (OXYTOCIN).; TRANEXAMIC ACID (TRANEXAMIC ACID).
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 80 KG