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

Model Number	M00562670
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Failure to Cut (2587)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare device was used during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was unable to open, thus it was unable to completely cut through the polyp.The snare was stuck around a pedunculated polyp, and they were unable to remove it during the case.The patient had to be sent to the hospital.The procedure was not completed due to the event.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare device was used during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was unable to open, thus it was unable to completely cut through the polyp.The snare was stuck around a pedunculated polyp, and they were unable to remove it during the case.The patient had to be sent to the hospital.The procedure was not completed due to the event.There were no patient complications reported as a result of this event.Correction noted on march 19, 2025.The correct procedure date is (b)(6) 2025.Additional information received on march 17, 2025 it was confirmed that the type of treatment the patient had at the hospital was an endoscopic procedure.The polyp was incompletely resected piecemeal by hot snare.The entrapped snare was dislodged and retrieved with rat tooth forceps.Four clips were placed for hemostasis.Additionally, the patient was admitted for monitoring overnight, with plan to repeat colonscopy after 3 months.
Additional Manufacturer Narrative
Block h2: correction.Block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled/rescheduled.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2202 captures the reportable event of an endoscopic procedure.Imdrf device code a050702 captures the reportable event of loop failure to cut.Imdrf device code a150208 captures the reportable event of entrapment of device.Block h11: correction: block b5 (describe event or problem) has been corrected.

• 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: 21322853
• Report Number: 3005099803-2025-00272
• Device Sequence Number: 12729226
• Product Code: FDI
• UDI-Device Identifier: 08714729748083
• UDI-Public: (01)08714729748083(17)260116(10)30869617
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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 Expiration Date: 01/16/2026
• Device Model Number: M00562670
• Device Catalogue Number: M00562670
• Device Lot Number: 0030869617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 01/17/2023
• 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
• Patient Sex: Unknown