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

Model Number	FG-0202
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Air Embolism (1697); No Code Available (3191)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date 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
It was reported to boston scientific corporation on november 26, 2019 that a symphion fluid management accessory was used in a hysteroscopy with myomectomy procedure in the uterus performed on (b)(6) 2019.According to the complainant, during procedure, the physician was resecting a very large fibroid when the tissue sack became full.When they changed the fluid management kit it would not prime.Reportedly, the patient was admitted to the hospital due to the risk of embolism.In the physicians assessment air was push into the patient's blood vessels when the fluid management kit was switched.The procedure was cancelled due to this event.As of (b)(6) 2019, the patient's condition was reported to be fine.

• 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
• MDR Report Key: 9488718
• Report Number: 3005099803-2019-06119
• Device Sequence Number: 1878542
• Product Code: PGT
• UDI-Device Identifier: 08714729863717
• UDI-Public: 08714729863717
• 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): 12/18/2019

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-0202
• Device Catalogue Number: 74052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/18/2019
• 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: Required Intervention