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

Event Date 11/30/2022

Event Type  Injury  

Event Description

The device did not control the bleeding [device ineffective].Blood was clotting and getting clogged in the tubing [device occlusion].Cthe suction was hooked up to the end of the device before it was turned on./connected it to suction prior to proper placement [wrong technique in device usage process].Case narrative: this initial spontaneous report originating from the united states, was received from a physician via customer account specialist, referring to a non-pregnant female patient of an unknown age.This report concerned 1 patient and 1 device.The patient's medical history included single pregnancy and vaginal delivery.The patient¿s concurrent condition included submucosal fibroid, uterine atony and retained placenta.On (b)(6) 2022 03:00 am, in the operating room, the patient lost 2000 cubic centimeter (cc) of blood and had a dilation and curettage (d&c) where ¿pieces of placenta were found¿.Concomitant medications included carboprost tromethamine (hemabate), misoprostol (cytotec) and methylergometrine maleate (methergine).No blood products were required during peripartum period.There was no invasive placenta.On that day on (b)(6) 2022), after the d&c, the patient had vacuum-induced hemorrhage control system (jada system) insertion (lot#, serial # and expiration date were not reported) via vaginal route for postpartum hemorrhage by the attending physician and other staff (the operator had received training on how to use the device on (b)(6) 2022).The device came with a blue seal valve kit and green carton.120 cc was inserted into the cervical seal.There was a user error.The suction was hooked up to the end of the device before it was turned on (wrong technique in device usage process).It was reported that "blood was clotting and getting clogged in the tubing" (device occlusion) and an ultrasound was performed to check if device was folded over on itself and to ensure correct placement of the device.The placement position was confirmed but the blood was continuing to get clogged and "no blood was going into the canister¿.The device did not control the bleeding (device ineffective).It was also reported that the device worked without issue, but bleeding continued.The patient then had a bakri uterine bleeding tamponade placed that controlled the bleeding.On the same day, vacuum-induced hemorrhage control system (jada system) removed.Maternal admission to intensive care unit (icu) was not required.The device was not removed and reinserted for any reason.The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the events device ineffective was determined to be serious as an intervention was required.Follow-up information was received on 05-dec-2022 from the physician.Provider stated that the patient was term at 39 weeks, had a history of gestational hypertension, and 5 previous live births (gravida 6, para 5), unknown if any previous post-partum hemorrhage.Provider states there was no uterine injury and the estimated blood loss at delivery was 2800ml.Disseminated intravascular coagulation (dic) was not diagnosed.It was reported that the patient did not have retained placenta, but a submucosal fibroid was found when she was performing an ultrasound.Another provider was setting up and inserting the device and connected it to suction prior to proper placement and blood was clotting in the tube.Indwelling time of the device was 5 minutes as the patient was bleeding around it and filling with clots.Provider states the event was operator error, not due to device malfunction and she contacted the rep to obtain further instructional information for their team.Team.No further information was known or available at this time.Medical device reporting criteria: serious injury.(b)(4).

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: 15951724
• MDR Text Key: 305191497
• Report Number: 3002806821-2022-00020
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: CYTOTEC (MISOPROSTOL),; HEMABATE (CARBOPROST TROMETAMOL),; METHERGINE (METHYLERGOMETRINE MALEATE),
• Patient Outcome(s): Required Intervention
• Patient Sex: Female