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

Model Number	M00562650
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of inability to generate energy.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the nurse in charge contacted the manager to report that a large polyp in the sigmoid colon measuring 2.5cm was completely encircled by a snare, but no electrical current was passing through it.The nursing staff made several attempts to reconnect and replace the erbe machine, but still unsuccessful.While still on the phone, the electrical current suddenly started working again for an unknown reason and as a result, the polyp was successfully removed.The procedure was completed with a similar sensation large oval med stiff snare there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of unable to deliver energy.Block h10 investigation results: one sensation snare was received for analysis.Visual and microscope analysis of the returned device found the working length was deformed and the loop was bent.Functional analysis of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended well.The device was tested with different brands of active cords and it was compatible with all of them.Electrical analysis was also performed and the device's electrical resistance was within specification.The reported event of "device failure to deliver energy could not be confirmed no issues were noted with the electrical device testing during electrical test upon return.Device analysis found that the working length was deformed and the loop was bent.It is likely that this is due to an excess of manipulation of the device.It is most likely that during manipulation of the device an excess of force was applied to the device such as the interaction with the scope or additional tools/medical devices, causing the device to separate in two pieces.Therefore, based on analysis of the returned device and all available information, the most probable cause for the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the nurse in charge contacted the manager to report that a large polyp in the sigmoid colon measuring 2.5cm was completely encircled by a snare, but no electrical current was passing through it.The nursing staff made several attempts to reconnect and replace the erbe machine, but still unsuccessful.While still on the phone, the electrical current suddenly started working again for an unknown reason and as a result, the polyp was successfully removed.The procedure was completed with a similar sensation large oval med stiff snare 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 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: 17598168
• Report Number: 3005099803-2023-04221
• Device Sequence Number: 15341509
• Product Code: FDI
• UDI-Device Identifier: 08714729748069
• UDI-Public: 08714729748069
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 04/26/2024
• Device Model Number: M00562650
• Device Catalogue Number: 6265S
• Device Lot Number: 0027210744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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 Sex: Unknown