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

Model Number	FLT-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Fluent console s/n (b)(6) was investigated.The reported complaint describes that an abnormal pressure drop occurred during a procedure.To test for this failure, a functional flow test was conducted where the flow packs, supply bag, waste bag, and supply of water were connected and primed.Here, it was observed that the console ran though the supply of water with no issues found.The pressure was changed from 80 mmhg to 60 mmhg during the test.Hence, the failure mode reported by the customer was not replicated during investigation.A visual inspection was conducted and found that the left waste hook was deformed as it was angled downward.A device history record (dhr) review was conducted for the reported 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.

• Brand Name: FLUENT CONSOLE
• Common Device Name: 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
• Report Number: 1222780-2022-00192
• Device Sequence Number: 6912358
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: FLT-100
• Device Catalogue Number: FLT-100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 12/31/2024
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/18/2022; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLT-112S
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female