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

Model Number	M00562673
Medical Device Problem Codes	Retraction Problem (1536); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report # 3005099803-2023-05377 for the other associated device information.It was reported to boston scientific corporation that a sensation medium oval snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare loop was placed around the polyp which was smaller than 27mm in size, however the loop would not close around the polyp.As a result, the polyp could not be removed.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of unable to cut.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17919883
• Report Number: 3005099803-2023-05376
• Device Sequence Number: 6782670
• Product Code: FDI
• UDI-Device Identifier: 08714729501664
• UDI-Public: 08714729501664
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/12/2023

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 Expiration Date: 07/30/2026
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Device Lot Number: 0032122431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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
• Patient Sex: Unknown