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

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

Patient Problems Hemorrhage/Bleeding (1888); Damage to Ligament(s) (1952)

Event Type  Injury  

Event Description

One did not work/ jada device stop control the bleeding? no [device ineffective].It was a ligament bleed [ligament disorder].Case narrative: this spontaneous report originating from the united states was received from a nurse unit manager (also reported as "office manager") via clinical sales educator (cse), referring to a female patient of an unknown age.The patient's historical conditions included pregnancy and delivery.The patient's current conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route for post-partum hemorrhage.The reporter stated that the vacuum-induced hemorrhage control system (jada system) did not work (also reported as "did not control the bleeding") (device ineffective), but it was a ligament bleed (ligament disorder).The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.The outcome of ligament disorder was unknown.The reporter's causality assessment was not provided.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).Follow up information was received from an unspecified reporter via clinical account specialist (cas) on (b)(6) 2023.The patient was reported to be 19 years old.Her current conditions included gravida 3 and para 1.She was 38 weeks pregnant when she went to caesarean section after a failed induction.In the operating room (or), her cumulative blood loss (qvl) was 1170 (units unspecified).She was given misoprostol (cytotec) 800 mcg, but she experienced another 450 ml of blood loss.After surgery, the provider attempted to place vacuum-induced hemorrhage control system (jada system), however the tubing was not long enough to reach the suction source in the or.The provider initially attempted to use extension tubing, but the lengthy tubes prevented adequate suction from reaching the patient.The provider moved the patient and the or table closer to the suction source so they could use the vacuum-induced hemorrhage control system (jada system) without extension tubes.This allowed the vacuum-induced hemorrhage control system (jada system) to work properly and the uterus gained tone, however, the patient continued to experience bleeding so the patient was sent to interventional radiology with portable suction and discovered that the patient had 2 uterine arteries on the right side and 1 uterine artery on the left side, which the provider noted to be out of the ordinary.Provider performed uterine artery embolization, and noted that it seemed to work for the patient.The patient did not have to have a hysterectomy.The providers did not know why the bleeding occurred but expressed that they believed the device functioned properly.In the end, the patient had a qvl of 6500 (units specified) and total 1500 ml of blood loss.Upon internal review, the event of device ineffective was considered to be serious due to the required intervention.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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

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: 17642933
• MDR Text Key: 322187642
• Report Number: 3002806821-2023-00103
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female