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

Model Number RM-FLT-100

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

Patient Problem Pulmonary Embolism (1498)

Event Date 09/30/2020

Event Type  Death  

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 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
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: maria pecho ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 10759216
• MDR Text Key: 213833567
• Report Number: 1222780-2020-00145
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552(11)190411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RM-FLT-100
• Device Catalogue Number: RM-FLT-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2019
• 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
• Treatment: MYOSURE TISSUE REMOVAL DEVICE - 30-401LITE
• Patient Outcome(s): Death