MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number	FG-0201
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Death (1802); Perforation (2001); Sepsis (2067)
Date of Event	06/18/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
This manufacturer report pertains to one of two symphion resecting device that were used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2019 that two symphion resecting devices were used in a hysteroscopy with dilatation and curettage procedure performed on (b)(6) 2019.According to the complainant, the procedure started normally.During hysteroscopy, the physician noted that there was a pathology in the uterine cavity.The physician used resecting device and about 2 to 3 minutes of resection, the symphion system alarmed "check the system for leak".Reportedly, there was no fluid coming out of the cervix and the patient was losing fluid at a faster rate than normal.During this time, the visualization of the cavity was impaired and it was recommended to stop the procedure.The procedure was aborted and the total fluid deficit was 700 ml.The vital signs of the patient were stable at the time the procedure was aborted.Several days post procedure, it was reported that the patient went back to the hospital due to a perforation.The patient underwent multiple surgeries and died due to sepsis.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a follow-up report will be submitted.

• Brand Name: SYMPHION
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8865455
• Report Number: 3005099803-2019-03974
• Device Sequence Number: 2537006
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-0201
• Device Catalogue Number: 74080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other