MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA SYSTEM

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

Patient Problem Rupture (2208)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

The acessa procedure was completed on (b)(6) 2017, approximately two years prior to the reported incident, after a hysteroscopic myomectomy - myosure procedure, according to the dr.And acessa sales person.The acessa portion of the two-part surgery included treatment of two subserosal (on the outside of the uterus) fibroids.Fibroid #1 size was 2cm and fibroid # 2 size was.25 cm.Details for the hysteroscopic myomectomy myosure procedure were not provided.The dr.Stated that hologic, the company associated with myosure, was being contacted as well in relation to this incident.In 2014, the patient also had a cervical excision leep procedure performed that involved a cone resection of the cervix; size on pathology was 1.3 x 1.2 cm with a depth of 0.3 cm.On the day prior to the incident of the uterine rupture, (b)(6) 2019, the patient who was (b)(6) pregnant came in for contractions but was sent home.The patient came back the next day for contractions again but was sent home.The patient did not leave the facility however as she had a prenatal appointment in the same building with her obgyn.The dr.Saw the patient and sent the patient to labor and delivery again because she was in labor, she subsequently ruptured and had an emergency c-section.The patient was discharged home the same week, while the baby remained at the hospital under observation at the time of the complaint.Although, the initial reporter contacted acessa about this event, the associate general counsel for the hospital later stated that they would not be sharing any further information and that the physician that originally initiated the complaint should not have reached out to acessa and had contacted acessa health inc.In error.Per an evaluation by individuals with the appropriate medical expertise, the multi-variant nature of previous surgeries and circumstances surrounding her multi-day contractions, it is not likely that the acessa device caused or contributed to the event.There was no evidence of a potential acessa device related cause or malfunction based on the reported information or investigation results.There were no reported incidents or complaints of acessa product failure or patient complication at the time this acessa procedure case was completed and there is no indication of a product quality deficiency with respect to manufacture, design or labeling.Review of the appropriate acessa users guide for the time frame of the acessa procedure indicates that the device instructions for use (ifu) lists applicable complications and provides applicable warnings, precautions and use instructions.Reference warnings and precautions specific to uterine fibroid ablation states that "insufficient data exist on which to evaluate the safety and effectiveness of acessa procedure in women who plan future pregnancy.Therefore, the acessa procedure is not recommended for women who are planning future pregnancy." due to the lack of response for information from the associated hospital and the complaint initiator, further complaint investigation cannot be completed.Based on the details of the investigation and the statements provided by the hospitals risk management department that acessa was contacted in error, acessa has determined that the acessa device is not related to the complaint event.The complaint will be closed and the mdr will be reported out of an abundance of caution and to appropriately document the complaint investigation results.The information submitted reflects all relevant data received.If additional relevant info is received, a supplemental report will be submitted.

Event Description

On may 30, 2019, it was reported that a patient had a ruptured uterus during labor on (b)(6) 2019, which required an emergency c-section.This incident did not occur during an acessa procedure.The dr.Stated that since the patient had received the acessa procedure previously in her medical history, that acessa was being notified of the incident.

• Brand Name: ACESSA SYSTEM
• Type of Device: ACESSA
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd.; bdg. 3, ste. 200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 7004 bee cave rd.; bldg. 3, ste. 200; austin TX 78746
• Manufacturer Contact: isaac rodriguez ; 7004 bee cave rd.; bldg. 3, ste. 200; austin, TX 78746 ; 5127850707
• MDR Report Key: 8746538
• MDR Text Key: 149627100
• Report Number: 3006443171-2019-00002
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR