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

Model Number JADA-1001

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

Patient Problems Coagulation Disorder (1779); Disseminated Intravascular Coagulation (DIC) (1813); Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/25/2021

Event Type  Injury  

Event Description

Information has been received from an investigator concerning a 41-year-old asian (hispanic or latino) female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada system - a post-market registry".The subject (gravida 1, para 1 (g1p1) had no past history of postpartum uterine bleeding or other significant medical problems.On (b)(6) 2021, the subject presented for an induced delivery at 39.4 weeks gestational age.On admission, her hemoglobin (hgb) was 12.4 gram per deciliter (g/dl).Trial of labor after cesarean (tolac) was done status post (s/p) induction of labor (iol) with cervical balloon and oxytocin (pitocin) (for 18 hours) complicated by shoulder dystocia and second degree perineal laceration.Intrapartum antibiotics (unspecified) for group b streptococcus (gbs) was also given.She received epidural anesthesia for delivery of an infant that weighed 3860 grams on 25-nov-2021.Delivery of intact placenta and membranes occurred.This was further complication by lower uterine segment atony and postpartum hemorrhage (pph) s/p uterine massage and uterotonics.There was lower uterine segment (lus) bleeding involved in this event.Prior to vacuum-induced hemorrhage control system (jada sytem) insertion, this subject received misoprostol, carboprost (1 dose), tranexamic acid (txa) (1 dose), and methergine (1 dose).The cumulative blood loss prior to the vacuum-induced hemorrhage control system (jada system) insertion was noted as 1000 milliliter (ml).On that day (25-nov-2021), vacuum-induced hemorrhage control system (jada system) (lot number, expiration date not reported) was placed vaginally for pph by a physician in the labor and delivery (l&d) department).However, heavy bleeding continued around the device (device ineffective) and was oozing from laceration without clotting concerning for disseminated intravascular coagulation (dic) (also reported as "cid").The vacuum-induced hemorrhage control system (jada system) was removed on the same day.Massive transfusion protocol (mtp) was called.The subject was transferred to the operating room (or) for further exploration and resuscitation.The subject underwent primary closure of perineal laceration with hemostasis, s/p placement of quick clot vaginally.Preoperative (pre-op) labs was consistent with dic.She was transferred to surgical intensive care unit (sicu) for further monitoring.No time was noted in documentation regarding time of vacuum-induced hemorrhage control system (jada system) placement or removal.The events caused prolonged hospitalization.The total indwelling time for vacuum-induced hemorrhage control system (jada system) was not documented and the total amount of blood collected in the canister during jada treatment was documented as 0 ml.The total cumulative blood loss for the event was 3500 ml.The subject was treated with carboprost (1 dose), tranexamic acid (txa) (1 dose), nine units of red blood cells, five units of platelets, two units of cryoprecipitate, vaginal quick clot and five units of fresh frozen plasma for abnormal postpartum uterine bleeding/pph and dic after treatment was initiated with vacuum-induced hemorrhage control system (jada system).Postpartum antibiotic ("ertapenem (ivanz)") was given for pph.The suspected cause of pph was uterine atony and coagulopathy.The subject was discharged on (b)(6) 2021.On discharge, her hgb was 8.9 g/dl.The outcome of dic was unknown.The causal assessment was not reported.The events were considered to be life-threatening.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Medical device reporting criteria: serious injury.(b)(4).

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 41-year-old asian (hispanic or latino) female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada system - a post-market registry".The subject (gravida 1, para 1 (g1p1) had no past history of postpartum uterine bleeding or other significant medical problems.On (b)(6) 2021, the subject presented for an induced delivery at 39.4 weeks gestational age.On admission, her hemoglobin (hgb) was 12.4 gram per deciliter (g/dl).Trial of labor after cesarean (tolac) was done status post (s/p) induction of labor (iol) with cervical balloon and oxytocin (pitocin) (for 18 hours) complicated by shoulder dystocia and second degree perineal laceration.Intrapartum antibiotics (unspecified) for group b streptococcus (gbs) was also given.She received epidural anesthesia for delivery of an infant that weighed 3860 grams on (b)(6) 2021.Delivery of intact placenta and membranes occurred.This was further complication by lower uterine segment atony and postpartum hemorrhage (pph) s/p uterine massage and uterotonics.There was lower uterine segment (lus) bleeding involved in this event.Prior to vacuum-induced hemorrhage control system (jada sytem) insertion, this subject received misoprostol, carboprost (1 dose), tranexamic acid (txa) (1 dose), and methylergometrine maleate (methergine) (1 dose).The cumulative blood loss prior to the vacuum-induced hemorrhage control system (jada sytem) insertion was noted as 1000 milliliter (ml).On that day ((b)(6) 2021), vacuum-induced hemorrhage control system (jada sytem) (lot number, expiration date not reported) was placed vaginally for pph by a physician in the labor and delivery (l&d) department).However, heavy bleeding continued around the device (device ineffective) and was oozing from laceration without clotting concerning for disseminated intravascular coagulation (dic) (also reported as "cid").^^it was reported that the subject was in dic at the time of vacuum-induced hemorrhage control system (jada sytem) placement.Vacuum-induced hemorrhage control system (jada sytem) was inserted knowing that the subject was in dic.Things happened very fast and the device worked well, but with dic, there was simply just bleeding around vacuum-induced hemorrhage control system (jada sytem)^^.The vacuum-induced hemorrhage control system (jada sytem) was removed on the same day.Massive transfusion protocol (mtp) was initiated ^^since the subject was bleeding even around vacuum-induced hemorrhage control system (jada sytem) and from other sites^^.The subject was transferred to the operating room (or) for further exploration and resuscitation.The subject underwent primary closure of perineal laceration with hemostasis, s/p placement of quick clot vaginally.Preoperative (pre-op) labs was consistent with dic.She was transferred to surgical intensive care unit (sicu) for further monitoring.No time was noted in documentation regarding time of vacuum-induced hemorrhage control system (jada sytem) placement or removal.The events caused prolonged hospitalization.The total indwelling time for vacuum-induced hemorrhage control system (jada sytem) was not documented and the total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada) treatment was documented as 0 ml.The total cumulative blood loss for the event was 3500 ml.The subject was treated with carboprost (1 dose), tranexamic acid (txa) (1 dose), nine units of red blood cells, five units of platelets, two units of cryoprecipitate, vaginal quick clot and five units of fresh frozen plasma for abnormal postpartum uterine bleeding/pph and dic after treatment was initiated with vacuum-induced hemorrhage control system (jada sytem).Postpartum antibiotic ("ertapenem (ivanz)") was given for pph.The suspected cause of pph was uterine atony and coagulopathy.The subject was discharged on 29-nov-2021.On discharge, her hgb was 8.9 g/dl.^^lot number was requested but he reporter did not have the lot number of vacuum-induced hemorrhage control system (jada sytem)^^.The event was considered to be life-threatening.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Updated information received on 10-may-2022 from the investigator has been captured in between double caret (^^).The event dic was deleted and updated as concurrent condition.Additionally, reporter details were updated.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): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.) 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): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer Contact: 3495 edison way; menlo park, CA 94025
• MDR Report Key: 14458983
• MDR Text Key: 292195523
• Report Number: 3017425145-2022-00096
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• 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 Number: 1
• Treatment: PITOCIN [OXYTOCIN] (OXYTOCIN) 11/25/2021 TO UNK; PITOCIN [OXYTOCIN] (OXYTOCIN) 11/25/2021 TO UNK
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: Asian