MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE XL; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 50-501XL

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

Patient Problems Bradycardia (1751); Abdominal Distention (2601)

Event Date 07/19/2023

Event Type  Death  

Manufacturer Narrative

Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.2 devices where involves in this event: 1222780-2023-00361.

Event Description

It was reported that a myosure procedure was performed for the treatment of fibroid on (b)(6), the visibility was good, and no signs of perforation or damage during the procedure, diagnostic hysteroscopy was performed with a versa scope and then switched to an omni scope with the intention to use the myosure xl.The first myosure xl device did not plug in at the fluent end and thus did not come in contact with the patient and i had requested it to be put aside to be reported to the company.This device has unfortunately been disposed of after the incident.The next myosure xl did connect and the resection was not optimal due to the large size of the fibroid and the fact it was calcified too.The fluid deficit mark of 2.1 was reached and the fluent system alarmed, and they noted there was a large amount of fluid loss on the incontinence pad on the floor amounting to about 2 litres.They attached the next giving bag as the first bag had finished and continued the procedure as the doctor was happy that the fluid deficit was not >500mls or 600 mls.The staff then noted that the fluid deficit reached 2.2 and the machine alarmed much sooner than the first bag this time and at this point still did not see any identifiable signs of perforation via the scope.They stopped the procedure as the fluid deficit was 2.6 liters.Pre-procedure bp was 120/80, it had dropped to 96/50 by 7 minutes into the procedure when the diagnostic scope was completed using a versa scope.The patient had a large fibroid uterus with a cavity size of 10 cm and a very large submucous fibroid occupying most of the cavity including the lower segment.Post procedure the patient showed a sudden drop to systolic of 40 mm of mercury.There was no active vaginal bleeding or loss of view during the resection or after the completion of the procedure.The anesthetist noted that the patient's abdomen was distended when he alerted the drop in bp and they proceeded to resuscitation and an emergency laparotomy and requested additional help.A fast uss prior to laparotomy confirmed hemoperitoneum.On laparotomy they found a large amount of blood mixed with fluid amounting to about 3 to 3.5 liters defect of about 1 cm about 2 cm lateral to the lower uterine segment on the left side broad ligament close to the pelvic side wall.The junior doctor who was assisting, unfortunately, tore this peritoneum medially and, stated there was a 1cm defect in the lower segment of the uterus on the lateral aspect which was an area they never approached during the scope.There was no active bleeding from this defect at the time of laparotomy.In her effort, to lift the uterus out of the pelvis, the trainee doctor unfortunately had her finger in the defect during traction which led to a tear on the left anterolateral aspect of the uterus opening the whole cavity.There was bleeding from the torn edges due to the circulatory shutdown leading to shock.The staff proceeded to undertake a subtotal hysterectomy as the resuscitation was in progress.Unfortunately, the resuscitation was not successful, and the patient was declared dead after almost 1.5 hours of resuscitation.The doctor is not sure if there was a tear in the wall of the uterus due to the pressure and stretching if the lower segment had plugged this tear during the resection or if was there a rupture of a vessel in the peritoneum as neovascularisation is not uncommon in presence of fibroids.All devices are unfortunately disposed of as per the theatre team.No additional information available.

• Brand Name: MYOSURE XL
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 17839878
• MDR Text Key: 324548630
• Report Number: 1222780-2023-00360
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420035507654
• UDI-Public: (01)15420035507654(17)251025(10)22L10RA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 22L10RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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 Outcome(s): Death; Required Intervention
• Patient Sex: Female