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

Model Number DGN-538

Device Problems Structural Problem (2506); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  malfunction  

Event 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¿
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 9161719
• MDR Text Key: 161422007
• Report Number: 9161719
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: (01)10840253107425
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DGN-538
• Device Lot Number: 23560113
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Weight: 79