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 Disseminated Intravascular Coagulation (DIC) (1813); Hypovolemic Shock (1917)

Event Date 04/21/2023

Event Type  Injury  

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.

Event Description

Was dic diagnosed? yes, after jada/consumer went into dic [disseminated intravascular coagulation].Hypovolemic shock [hypovolaemic shock].Did the jada device stop control the bleeding? no [device ineffective].Jada collected approximately 150ml of blood in the tubing however clotting interrupted continued suction.[device occlusion].Case narrative: this initial spontaneous report originating from the united states was received from a physician via clinical educator (ce) referring to a 22-year-old female patient.The patient's gravida was 3 and para was 2.This report concerned 1 patient and 1 device.It was reported that patient was seen on (b)(6) 2023 for a scheduled caesarean (c)-section with planned bilateral tubal ligation.The patient had no uterine atony at delivery on (b)(6) 2023 and postpartum hemorrhage called 15 minutes after delivery, delivery was not induced.Patient was given carboprost trometamol (hemabate), oxytocin, and tranexamic acid (txa).On the same day, the patient was inserted with vacuum-induced hemorrhage control system (jada system), 1 device via vaginal route by attending physician for postpartum hemorrhage (postpartum haemorrhage).The estimated blood loss (ebl/qbl) prior to vacuum-induced hemorrhage control system (jada system) use was reported as 3175 (unit not reported).Immediately after vacuum-induced hemorrhage control system (jada system) placed, patient was given rectal misoprostol (cytotec).Vacuum-induced hemorrhage control system (jada system) collected approximately 150ml of blood in the tubing however clotting interrupted continued suction (device occlusion).The vacuum-induced hemorrhage control system (jada system) did not control the bleeding (device ineffective).Obstetrician (ob) rapid response was initiated, and device was taken out after 10 minutes.Hysterectomy was performed on the same day on (b)(6) 2023 and patient was diagnosed with dic (disseminated intravascular coagulation).During peripartum the patient was given 2 units of red blood cell (rbc), 1 unit factor viii (antihaemophilic factor) (cryo) and 1 pack of platelets.The patient was sent to intensive care unit (icu) for recovery and monitoring for hypovolemic shock (hypovolaemic shock).Patient was given another unit of factor viii (antihaemophilic factor) (cryo) in the icu.The patient's hospitalization was prolonged due to the events.The patient sought medical attention.She was discharged on (b)(6) 2023 (also reported as "unknown how many days she was in the icu"), at the time of discharge her hemoglobin was 7.5 (unit not reported) and hematocrit was 24.2 (unit not reported).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 unknown.The outcome of disseminated intravascular coagulation and hypovolaemic shock was not reported.The reporter's causality assessment was not provided.Upon internal review, the events disseminated intravascular coagulation, device occlusion and hypovolaemic shock were determined to be medically significant.Upon internal review, the event device ineffective was determined to be serious due to 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.Therefore, priority quality investigation will not be completed.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).Fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).

• 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: 16919746
• MDR Text Key: 315101903
• Report Number: 3002806821-2023-00054
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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),; OXYTOCIN (OXYTOCIN),; TRANEXAMIC ACID (TRANEXAMIC ACID),
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 22 YR
• Patient Sex: Female