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

Model Number FG-0201

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

Patient Problem Bronchospasm (2598)

Event Date 03/21/2019

Event Type  malfunction  

Event Description

I do not know if the device caused/contributed to potential injury, but feel it is important to consider all factors involved in the adverse event this patient suffered.My patient experienced severe bronchospasm during surgery that could be entirely unrelated to the device being used.However, it is important to consider whether any new surgical device or treatment could increase the risk of anesthesia related complications such as bronchospasm.The device is a bipolar hysteroscopic tissue resection instrument that withdraws the tissue fragments and distension media, 0.9 normal saline, filters the tissue out along with any other particulate matter through a 40-micron filter unit before returning the distention media back to the circulation.During hysteroscopic tissue resection, it is possible for the distention media to enter the systemic circulation of the patient raising the possibility that some molecular agent precipitated the bronchospasm this patient has suffered.It is important to understand that a bronchospasm such as this can occur with any general anesthetic and surgical procedure and there is no indication that the device and the actual type of procedure being performed cause her bronchospasm.

• Brand Name: SYMPHION
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8636143
• MDR Text Key: 145975338
• Report Number: 8636143
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FG-0201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA