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	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff was used during an unknown procedure performed on (b)(6) 2022.It was reported that snare loop was unable to cut polyp when completely open.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff was used during an unknown procedure performed on (b)(6) 2022.It was reported that snare loop was unable to cut polyp when completely open.Additional information received on (b)(6) 2022.The device was used to remove a 40mm polyp in the sigmoid colon during a colonoscopy procedure.The snare was securely attached to the active cord and there were no visible problems with the cautery pins.The procedure was completed and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block g2: this complaint has an attached maude report number mw5112822.Block h11: blocks a1, a2, a3, a4, block e1 (initial reporter's details), block h6 (impact code) have been updated based on the additional information received on december 6, 2022.Blocks e4 and g2 have 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 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: 15851415
• Report Number: 3005099803-2022-06952
• Device Sequence Number: 5027412
• Product Code: FDI
• UDI-Device Identifier: 08714729748069
• UDI-Public: 08714729748069
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

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: 07/07/2024
• Device Model Number: M00562650
• Device Catalogue Number: 6265S
• Device Lot Number: 0027604447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 82 KG