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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

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ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Model Number JADA - 1001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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
Information has been received from an investigator concerning a 35-year-old white (not hispanic or latino) female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the vacuum-induced hemorrhage control system (jada system) system: a post-market registry".This report contains one subject and one medical device.The subject's concurrent conditions included cardiovascular disease and cephalosporin allergy.The subject, gravida 1 para 1 (g1p1), had a past history of postpartum uterine bleeding that was treated with uterotonics beyond oxytocin.On (b)(6) 2022, she presented for an induced delivery at (b)(6) weeks gestational age.On admission at 07:52, her hemoglobin (hgb) was 13.7 g/dl.She had an unassisted vaginal delivery and received oxytocin prior to delivery for 14 hours.She received epidural anesthesia for delivery of an infant that weighed 4200 g (macrosomia).The subject was noted to have postpartum hemorrhage (pph) related to uterine atony and retained placenta after her delivery.It was unknown if there was lower uterine segment (lus) bleeding involved in this event.Placental delivery occurred on the same day at 20:03.The cumulative blood loss prior to the vacuum-induced hemorrhage control system (jada system) insertion was noted as 2000 ml, which was severe postpartum hemorrhage (pph).Banjo curettage with ultrasound guidance performed to ensure all membranes were removed.Prior to vacuum-induced hemorrhage control system (jada system) insertion, the subject received carboprost (also reported as carboprost(hemabate)) (2 doses), tranexamic acid (txa) (1 dose), and methergine (1 dose).Oxytocin (pitocin) was turned to 900.A postpartum hemorrhage code was called in order to facilitate a second intravenous (iv), laboratory tests, anesthesia assistance.The subject remained hemodynamically stable throughout this.At 20:20, vacuum-induced hemorrhage controlsystem (jada system) was inserted (uterine tamponade with 60cc placed in vaginal balloon and suction to 80mmhg, lot and expiration date not reported), by a resident, 17 minutes after delivery of the placenta.The total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada system) treatment was documented as 1000 ml.The subject was treated with carboprost (2 doses), txa (1 dose), misoprostol (also reported as misoprostol (cytotec)), three units of red blood cells, and one unit of fresh frozen plasma after treatment initiated with a vacuum-induced hemorrhage control system (jada system).The subject received postpartum antibiotics (gentamicin and clindamycin) for vacuum-induced hemorrhage control system (jada system) use and manual removal of placenta.Preliminary results of a rotational thromboelastometry (rotem) were normal.Stat complete blood count (cbc) was done with hematocrit of 34 (units not provided) down from 42 (units not provided) on admission.Platelets was at 113 (units not provided).Vacuum-induced hemorrhage control system (jada system) did not control postpartum bleeding (device ineffective).It was reported that the event caused prolonged hospitalization.Consult was then placed to interventional radiology for uterine artery embolization given hemodynamic stability and continued uterine bleeding with estimated blood loss (ebl) approaching 3 l.The subject intermittently required oxygen however denied any shortness of breath or chest pain and low suspicion for pulmonary edema or transfusion reaction at that time.The total blood loss for this case was 3000 ml.Vacuum-induced hemorrhage control system (jada system) was removed on (b)(6) 2022 06:45.The total in-dwelling time for vacuum-induced hemorrhage control system (jada system) was 10.42 hours.She was discharged from the hospital on (b)(6) 2022 17:41.Her hgb at discharge was noted at 8.1 g/dl.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 available.The event of device ineffective was considered to be serious as an intervention was required (uterine artery embolization).Medical device reporting criteria: serious injury (b)(4).
 
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Brand Name
JADA SYSTEM
Type of Device
INTRAUTERINE VACUUM CONTRACTION SYSTEM
Manufacturer (Section D)
ALYDIA HEALTH
3495 edison way
menlo park CA 94025
Manufacturer (Section G)
ALYDIA HEALTH
3495 edison way
menlo park CA 94025
Manufacturer Contact
heather wisler
3495 edison way
menlo park, CA 94025
8445232666
MDR Report Key14375311
MDR Text Key294770585
Report Number3017425145-2022-00090
Device Sequence Number1
Product Code OQY
UDI-Device Identifier00850017882003
UDI-Public(01)00850017882003
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/12/2022
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? No
Device Operator Health Professional
Device Model NumberJADA - 1001
Device Catalogue NumberJADA-1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/27/2022
Initial Date FDA Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MISOPROSTOL (MISOPROSTOL) (B)(6) 2022 TO UNK; TRANEXAMIC ACID (TRANEXAMIC ACID) (B)(6) 2022 TO; CARBOPROST (CARBOPROST) (B)(6) 2022 TO UNK; FRESH FROZEN PLASMA (BLOOD PLASMA) (B)(6) 2022 T; RED BLOOD CELLS (RED BLOOD CELLS) (B)(6) 2022 TO
Patient Age35 YR
Patient SexFemale
Patient Weight80 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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