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

Model Number 08714729748106

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

During colonoscopy procedure, there was a malfunction in the 13mm snare when opening and closing the device to retrieve a colon polyp in the transverse colon.The snare did not open and close easily, the polyp, however, was able to be removed with the snare in use.Manufacturer response for snare, sensation short throw 13mm (per site reporter).Equipment reported to customer service.Equipment is available for return to manufacturer for investigation.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 17189839
• MDR Text Key: 317745534
• Report Number: 17189839
• Device Sequence Number: 1
• Product Code: FDI
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08714729748106
• Device Lot Number: 30484940
• 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: 06/16/2023
• Event Location: Other
• Date Report to Manufacturer: 06/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White