MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00562690

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Polypectomy snare became unraveled showing a piece of metal during the procedure.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15163214
• MDR Text Key: 297227573
• Report Number: 15163214
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729748106
• UDI-Public: (01)08714729748106
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562690
• Device Lot Number: 29083544
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Sex: Female
• Patient Weight: 98 KG