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

Model Number FG-0201

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Perforation (2001); Sepsis (2067)

Event Date 06/18/2019

Event Type  Death  

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 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
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): SMC COSTA RICA; edificio b48 avenida 0; ,; zona franca coyol, alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 8865455
• MDR Text Key: 153414378
• Report Number: 3005099803-2019-03974
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• 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: 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
• Device Operator: Health Professional
• Device Model Number: FG-0201
• Device Catalogue Number: 74080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other