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

Model Number	M00562650
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used for a polyp in the colon for a polypectomy procedure performed on (b)(6) 2024.During the procedure, on its first cut it loses quality and does not cut.The procedure was completed with another sensation short throw.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20510870
• Report Number: 3005099803-2024-05322
• Device Sequence Number: 15215060
• Product Code: FDI
• UDI-Device Identifier: 08714729748069
• UDI-Public: 08714729748069
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K941750
• 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): 10/22/2024

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: 08/21/2026
• Device Model Number: M00562650
• Device Catalogue Number: 6265S
• Device Lot Number: 0032272651
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 08/22/2023
• 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