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 Type  Injury  

Event Description

The vaginal bleeding continued [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified nurse via clinical account specialist (cas), referring to a female patient of unknown age.The patient's historical conditions included pregnancy and vaginal delivery.The nurse reported that the patient "passed-out" at home from bleeding (also reported as post-partum hemorrhage) at the 9-10 day mark and was taken to another facility and had lost approximately 5 liters of blood and had a dilation and curettage (d&c) performed prior to transfer to their facility.The patient was transferred from the other facility directly to intensive care unit (icu) (considered as hospitalization) at the current facility.The patient's current conditions also included uterine artery pseudoaneurysm and uterine atony.This report concerned 1 patient and 1 device.It was reported that the patient was treated with a bakri balloon (considered as concomitant therapy) at the previous facility, and on an unknown date, this was removed upon arrival at the current facility where the patient was evaluated by the attending physician and inserted with vacuum-induced hemorrhage control system (jada system) vaginally (lot #, serial # and expiry date were not reported) without difficulty for post-partum hemorrhage.It was not physician's first time using the device.Nurse reported that the vaginal bleeding continued (device ineffective), and the therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The patient was taken to interventional radiology (considered as prolonged hospitalization) where a uterine artery embolization was performed, and the bleeding resolved.The suspected cause of post-partum hemorrhage was reported as uterine artery pseudoaneurysm and uterine atony.Nurse also reported that the patient was also treated with 16 units of blood and remained alert and oriented throughout the treatment and procedures.There was no significant disability or incapacity, and the event was not life-threatening.More than one vacuum-induced hemorrhage control system (jada system) was not used.The device was not removed and reinserted.No additional adverse event (ae)/ product quality complaint (pqc) was identified.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was considered as serious as it 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).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).

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: 17085221
• MDR Text Key: 316879608
• Report Number: 3002806821-2023-00069
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female