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

Model Number JADA - 1001

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as "blood clotted in tubing - had to replace tubing.") has occurred with the jada system whereby if the suspected malfunction were to recur at a time when the patient was not under close observation, this malfunction could possibly cause or contribute to a death or serious injury.Out of an abundance of caution, the company will report this case as a malfunction mdr.Per the jada system ifu, "signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding.", "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada." and "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding.".

Event Description

Alydia health received a completed jada experience survey form on 04/07/2022 that reported jada stopped the postpartum hemorrhage (pph) but noted "blood clotted in tubing - had to replace tubing." in the area on the survey designated for feedback when 'jada did not stop bleeding'.This patient in this case is described as multiparous with having obesity, hypertension, pre-eclampsia, and fibroids.She has a history of pph with previous deliveries.She had a vaginal induction and her pph started within one hour after delivery.Prior to jada use she received cytotec (600 units) and txa (1 g).The patient's blood loss prior to jada use reported as 1357 ml.The cervical seal was reported as filled with 120 ml of sterile fluid.Jada was reported to have controlled the pph bleeding in "greater than 10 minutes." additional information provided after a phone discussion, "mom did fine, she had a known fibroid 10 cm, on mag, previous pph, gushed, did the sweep 1-2 times before placement, no methergine due to hypertension, used txa, clotting in the tube, not a good suction, 80 mm hg increased to 90 mm then exchanged wall tubing, flushed and worked much better, by the time she placed jada there was 1000 ml blood loss , 300 ml in cannister, patient went to ob special care unit because she was on mag, txa may have changed the blood, very aggressive bleed, 5-10 minutes after placental delivery jada was placed, hemabate given after device placed." the lot number is not currently available for this event.Multiple requests were sent to this site for lot number and or device retention, no response to this request to date.A good faith effort to an obtain lot number has been attempted.This site only has the jada 1001 model currently.This report will be amended if we receive additional information regarding this event.Following the attempt to treat pph that uterotonics failed to treat, a jada device was inserted.The health care provider reported jada stopped the bleeding within ten minutes, there was 325 ml in the jada canister; and "blood clotted in tubing - had to replace tubing." we are reporting this as a mdr in an abundance of caution.

• 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 Key: 14280042
• MDR Text Key: 290768031
• Report Number: 3017425145-2022-00081
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA - 1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• 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
• Patient Sex: Female