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); Hemorrhage/Bleeding (1888); Insufficient Information (4580)

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

Dic was diagnosed after jada use [disseminated intravascular coagulation] dilation and curettage (d&c) treatment was required after vacuum-induced hemorrhage control system (jada system) use to control the abnormal postpartum uterine bleeding or hemorrhage.[therapeutic product ineffective for unapproved indication] patient experienced "early spontaneous loss" of pregnancy, with gestational age "around 12ish weeks", and "the doctor had tried everything else" to stop the bleeding before obtaining a jada [device use issue] case narrative: this 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 condition included pregnancy and her current condition included hospitalization on an unknown date for early spontaneous loss of pregnancy, with gestational age "around 12ish weeks ".Her medical history, past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.Cas stated that on an unknown date, the doctor had tried everything else to stop the bleeding before obtaining a vacuum-induced hemorrhage control system (jada system) unit from labor and delivery.The vacuum-induced hemorrhage control system (jada system) was placed via an unknown route by the physician (device use issue) "because nothing was working" and the device "was successful in stopping the bleeding" (therapeutic product effective for unapproved indication).No additional details were available.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Fda code: (health effects - health impact per annex f): f24 insufficient information (it is not clear whether any health impact occurred, or health impact appears to have occurred, but there is not yet enough information available to classify the health impact).Follow up information was received from an unspecified nurse on 02-oct-2023.The gestational age at the time of abortion was reported as early second trimester and no agents were used.The patient had no invasive placenta and had no endometritis (infection of the uterus).Initially it was reported that the vacuum-induced hemorrhage control system (jada system) was successful in stopping the bleeding but later it was confirmed that dilation and curettage (d&c) intervention was performed as an escalating treatment after vacuum-induced hemorrhage control system (jada system) usage to control the abnormal post abortion uterine bleeding or hemorrhage (therapeutic product ineffective for unapproved indication) (hence preferred term (pt) was updated from therapeutic product effective for unapproved indication) (event onset: unknown date) (discrepant information: also reported as dilation and curettage (d&c) intervention was performed prior to vacuum-induced hemorrhage control system (jada system) usage).After vacuum-induced hemorrhage control system (jada system) usage, the patient was diagnosed with disseminated intravascular coagulation (dic) (event onset: unknown date).It was reported that the maternal admission to intensive care unit (icu) was required for a duration of 2 days (hospitalization prolonged) and unspecified blood products were required during peri abortion period.It was reported that after initial bleeding control by vacuum-induced hemorrhage control system (jada system), there was no bleeding episode and the duration of vacuum connection for vacuum-induced hemorrhage control system (jada system) to control the bleeding was 18 hours.The blood collected in the vacuum-induced hemorrhage control system (jada system) canister was 300 cubic centimeters (cc).It was reported that not more than one vacuum-induced hemorrhage control system (jada system) was used, and the operator of the device was the attending physician.The device was not removed and not reinserted for any reason and the abnormal post abortion uterine bleeding or hemorrhage was controlled both by vacuum-induced hemorrhage control system (jada system) and dilation and curettage (d&c) intervention.The outcome of disseminated intravascular coagulation was unknown (not reported).The reporter's causality assessment was not provided.Upon internal review, the event of disseminated intravascular coagulation and therapeutic product ineffective for unapproved indication was determined to be medically significant and hospitalization prolonged, and the event of therapeutic product ineffective for unapproved indication was considered 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.Medical device reporting criteria: serious injury.Imdrf code: (health effects - health impact per annex f): f19 surgical intervention (one or more surgical procedures, including percutaneous or minimally invasive procedures, were required, or an existing procedure changed.) imdrf code: (health effects - health impact per annex f): f0801 intensive care (patient requires admission to or extension of stay in an intensive care unit.) imdrf code: (health effects - health impact per annex f): f2302 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: 17893921
• MDR Text Key: 325237664
• Report Number: 3002806821-2023-00119
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Female