MAUDE Adverse Event Report: HOLOGIC, INC FLUENT CONSOLE; INSUFFLATOR, HYSTEROSCOPIC

Model Number FLT-100

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

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  Injury  

Event Description

It was reported that during a fluent procedure on (b)(6) 2022 while using the fluid management system (fluent), the physician noticed that the flow rate was high when at 80 mmhg; he then decided to decrease the intra uterine pressure to 60 mmhg.Suddenly, the tissue trap of the fluent system exploded, due to the pressure of the saline solution.At the same time, the patient's blood pressure dropped; the ph did drop as well (around 6 ¿ acidosis) and her body temperature at 34c.The anesthesiologist suspected a pulmonary embolism but was discarded.No injuries related to hypervolemia and fluid overload were reported and the patient was kept in observation , the patient did recover by that afternoon, and no other adverse events were noted: no neurological disorder observed.The patient was hospitalized for one night under observation.The next day, she was better and returned back home.The patient did not require additional treatment.No other information is available.

Manufacturer Narrative

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.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.Concomitant product used : flt-112s on the same date of the procedure.

• Brand Name: FLUENT CONSOLE
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 15042476
• MDR Text Key: 296067648
• Report Number: 1222780-2022-00192
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K180825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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: FLT-100
• Device Catalogue Number: FLT-100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FLT-112S
• Patient Outcome(s): Other
• Patient Sex: Female