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

Model Number	M00562690
Medical Device Problem Codes	Failure to Deliver Energy (1211); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw snare was used in the cecum during a colonoscopy procedure performed on (b)(6) 2025.During the procedure and inside the patient, a 3 cm pedunculated polyp was found at 40 cm.Initial attempts to remove it using a cold snare with energy were unsuccessful due to a lack of energy transmission.Despite changing the bovie pad and active cord and ensuring the snare was securely connected without issues at the cautery pin, coagulation still failed.The snare became stuck and could not be removed without risking injury.As a result, the handle was cut, and the wire was taped to the patient's thigh.The patient was sent to surgery the same day for device removal.Post-procedure testing confirmed that the erbe generator was functioning properly, as it worked with a hot biopsy forceps and was successfully used in a subsequent ercp.The procedure was completed successfully.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a150208 captures the reportable event of snare loop entrapment.Imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Imdrf impact code f19 captures the reportable event of surgical intervention.

• Brand Name: SENSATION SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22665659
• Report Number: 3005099803-2025-03589
• Device Sequence Number: 3824709
• Product Code: FDI
• UDI-Device Identifier: 08714729748106
• UDI-Public: (01)08714729748106(17)271122(10)35347598
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: M00562690
• Device Catalogue Number: M00562690
• Device Lot Number: 0035347598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown