MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 30-401LITE

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

Patient Problems Myocardial Infarction (1969); Pulmonary Edema (2020)

Event Date 12/28/2017

Event Type  Death  

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Use of sterile water for hysteroscopic distension media is known to be associated with severe complications including hemolysis and therefore is not recommended.[1],[2],[3].Indman pd, brooks pg, cooper jm, loffer fd, valle rf, vancaillie tg.Complications of fluid overload from resectoscopic surgery.J am assoc gynecol laparosc 1998;5:63-7.Indman pd, water should not be used for uterine distension.Am j obstet gynecol.2010; 202:e21-22.Aagl practice report: practice guidelines for the management of hysteroscopic distending media; j minim invasive gynecol.2013; 20:137-148.(b)(4).

Event Description

It was reported the patient underwent a hysteroscopy for post-menopausal bleeding on (b)(6) 2017 and the physician visualized a large intrauterine polyp.The physician then removed the polyp using a myosure lite disposable device.There was no fluid management system used; however, the physician used gravity to instill sterile water that was being used for the distention media.The exact fluid deficit amount was not provided, but reported as "substantial".There were no complications, other than false-tracking."the patient experienced pulmonary edema and cardiac arrest.She subsequently expired.Autopsy results were not available for review".On (b)(6) 2018, it was reported by the risk manager the fluid deficit was 1500ml.No additional information forthcoming.Based on the information provided, the myosure lite disposable device was not responsible for this patient developing pulmonary edema, cardiac arrest, and death.

• Brand Name: MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 7222650
• MDR Text Key: 98402914
• Report Number: 1222780-2018-00017
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 35420045505074
• UDI-Public: (01)35420045505074(10)17G10RA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/10/2020
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 17G10RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR