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

Model Number	M00562670
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a050702 captures the reportable event unable to cut.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used in a polypectomy procedure performed on (b)(6) 2024.During the procedure, the wire could not cut the polyp.The procedure was completed with another sensation short throw.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 short throw was used in a polypectomy procedure performed on (b)(6) 2024.During the procedure, the wire could not cut the polyp.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a050702 captures the reportable event unable to cut.Block h10: investigation results one sensation short throw snare was received for analysis.Visual analysis of the returned device revealed the working length was bent, and the loop was bent as well; a functional inspection performed and the device was extended and retracted in the 10- inch loop fixture and the loop could extend properly without any issue.No other device problems were noted.The reported complaint of loop failure to cut was unable to be confirmed.Upon analysis, it was found that the working length (distal part) was bent, and the loop was bent as well.These problems likely have occurred due the manner as the device was handled and manipulated may have caused the reported and encountered failures.Excessive manipulation of the device without enough care could have induced the defects found.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.

• 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: 19611049
• Report Number: 3005099803-2024-03004
• Device Sequence Number: 17881189
• Product Code: FDI
• UDI-Device Identifier: 08714729748083
• UDI-Public: 08714729748083
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Model Number: M00562670
• Device Catalogue Number: 6267S
• Device Lot Number: 0032782765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: Female