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

Model Number	RM-FLT-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	09/30/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A preliminary clinical evaluation summary has been provided by the gss head of clinical based on the information available at this time.Additional information has been requested from the tm to formulate a final clinical evaluation summary: "it is unlikely that either device fluent management system or myosure procedure resulted in or contributed to the patients death.The clinical history of multiple dvt in the le is a risk factor as well as patients age and would pre dispose any patient to increased risk of pe spontaneously or with any surgical intervention or procedure requiring anesthesia , and should have been cleared with a pre-operative h&p".Device history record (dhr) review was conducted for the identified serial number of the fluent console.No abnormalities were found related to the reported information.This device passed final testing prior to release.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Concomitant medical products: serial number of the myosure tissue removal device not provided by the complainant.
Event or Problem Description
It was reported that on september 28th doctor performed a myosure lite procedure on an (b)(6) patient who has high blood pressure and was post menopausal patient to obtain some samples.The deficit did not exceed 100 on the system and the techs did not do a manual count.Two days later the patient passed away from a pulmonary embolism.No further information was provided.

• Brand Name: FLUENT CONSOLE
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 10759216
• Report Number: 1222780-2020-00145
• Device Sequence Number: 3184971
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552(11)190411
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RM-FLT-100
• Device Catalogue Number: RM-FLT-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MYOSURE TISSUE REMOVAL DEVICE - 30-401LITE
• Outcome Attributed to Adverse Event: Death