MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESCUENET¿; SNARE, FLEXIBLE

Model Number	DGN-538
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Device is not stiff enough to use in a safe appropriate manner causing the scope to be entered in to the patient's mouth 3-4 times increasing the risk of aspiration.

• Brand Name: RESCUENET¿
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 9161719
• Report Number: 9161719
• Device Sequence Number: 2022731
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: (01)10840253107425
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/16/2019
• Report Date (Section F): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DGN-538
• Device Lot Number: 23560113
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 09/16/2019