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

Model Number	M00562690
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used during a colonoscopy with polypectomy procedure performed on (b)(6) 2023.During the procedure the snare did not coagulate, and the procedure time was extended due to increased bleeding of the patient.The procedure was completed with a similar sensation snare.There were no additional patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a07 captures the reportable event of suboptimal cautery.
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of suboptimal cautery.Investigation results: one sensation snare was received for analysis.Visual analysis of the returned device found the loop and the working length were bent.The 2 in 1 connector was dimensionally inspected and was found to be within specification.Electrical testing was performed, and the device's electrical resistance was within specification.No other device problems were noted.The reported event of "device delivers energy intermittently" could not be confirmed.Electrical testing was performed during product analysis and the device's electrical resistance was found to be within specification.Device analysis found the snare loop and working length were bent.This likely occurred due to the manipulation of the device during the procedure.Excessive force during handling or usage could result in device damage or loss of functionality.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected since the reported event could not be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used during a colonoscopy with polypectomy procedure performed on (b)(6) 2023.During the procedure the snare did not coagulate, and the procedure time was extended due to increased bleeding of the patient.The procedure was completed with a similar sensation snare.There were no additional 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: 16418358
• Report Number: 3005099803-2023-00363
• Device Sequence Number: 19655629
• Product Code: FDI
• UDI-Device Identifier: 08714729748106
• UDI-Public: 08714729748106
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 10/14/2025
• Device Model Number: M00562690
• Device Catalogue Number: 6269S
• Device Lot Number: 0030351607
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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