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

Model Number	M00560301
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf impact code f2202 captures the reportable event of an endoscopic procedure.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f1001 captures the reportable event of procedure cancelled/rescheduled - post sedation/sedation.Imdrf device code a150208 captures the reportable event of snare loop entrapment.
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare was used in the colon to remove polyps during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was closed around the polyp but was unable to reopen.It tightened around the polyp stalk and could not be loosened.The patient was subsequently transferred to another hospital for general surgery.There, the loop was removed using a proctoscope in a separate procedure.The proximal handle was cut off, and the snare was manipulated to loosen the wire.There were no patient complications reported as a result of this event.

• 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: 22425156
• Report Number: 3005099803-2025-03133
• Device Sequence Number: 12818604
• Product Code: FDI
• UDI-Device Identifier: 08714729283898
• UDI-Public: (01)08714729283898
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00560301
• Device Catalogue Number: 6030
• 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: 06/09/2025
• Initial Report FDA Received Date: 07/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown