MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM,

Model Number AQL-100CS

Device Problem Insufficient Information (3190)

Patient Problem Uterine Perforation (2121)

Event Date 07/17/2023

Event Type  Death  

Event Description

We have been informed of the following event: "technical support was contacted by a.Mirante - territory manager tm who reported that he was present for a tissue removal procedure using myosure and aquilex.The procedure was going normal the deficit was steady at 1000-1300 and would increase slightly while removing the tissue.The doctor then thought she saw something that looked like a perforation.At that point the deficit was increasing quickly, at 2500 the doctor stopped the procedure.The tm then left the room since the doctor mentioned that they were going to do an echocardiogram on the patient along with some other tests.This procedure took place around 9 am and later in the day he received a call from the doctor telling him that the patient had passed away.The cause of death was unknown.Myosure - case: (b)(4).".

Manufacturer Narrative

In the case described, a small perforation was assumed, which also explains the increase in deficit shortly after the perforation was assumed.Uterine perforation is a potential complication of all intrauterine procedures and can be associated with injury to surrounding blood vessels or other organs (e.G.Bladder or in-testine).If during a hysteroscopic procedure an obvious source of high fluid loss is not identified, laparoscopic assessment of potential cervical or uterine perforation should be made.The most probable cause is uterine perforation, which may have led to the death of the patient.Since the end user did not return the device and did not respond to further questions, we cannot rule out a malfunction of the device and therefore the event is reportable.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM,
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 17570491
• MDR Text Key: 321400523
• Report Number: 3002914049-2023-00007
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002121
• UDI-Public: 04056702002121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2023

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 Number: AQL-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female