MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number	FG-0201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device was 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
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device was used in a procedure performed on (b)(6) 2018.According to the complainant, during procedure and inside the patient, the resecting device was used to remove a fibroid in the uterus and the physician noticed that there was fluid deficit rising quickly.The procedure was stopped and a fluid deficit of 2000cc was noted.The physician suspected perforation but the patient's family refused to do additional laparoscopic procedure.The suspected perforation was not confirmed.Additionally, the fibroid was resected but half of the fibroid was free floating inside the patient.The floating fibroid was not retrieved and the patient is expected for evaluation a month after the procedure to check if the fibroid would naturally pass through or a second procedure is required.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7462351
• Report Number: 3005099803-2018-01339
• Device Sequence Number: 19112814
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/06/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2018
• Device Model Number: FG-0201
• Device Lot Number: 0064099478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: Other
• Patient Age: 40 YR