MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE

Model Number	M00562402
Medical Device Problem Codes	Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of energy generating issue.Imdrf device code a150208 captures the reportable event of loop entrapment.Imdrf device code a050702 captures the reportable event of loop cutting issues.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, dr.Nagesh attempted to remove a polyp in the descending colon using a 27 mm capliflex.The doctor ensured that all connections were properly checked before proceeding.However, it was noticed that the snare was not cutting as expected, even though all available pedals were used to generate current flow.As a result, the equipment was deemed non-functional.Despite multiple attempts by the physician and their team to remove the snare from around the polyp, they were unsuccessful.Eventually, they had to resort to cutting the flex wire and successfully removed the snare using a cold biopsy forceps.Some tissue was successfully removed as intended.The procedure was completed with a different device.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 captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, dr.(b)(6) attempted to remove a polyp in the descending colon using a 27 mm capliflex.The doctor ensured that all connections were properly checked before proceeding.However, it was noticed that the snare was not cutting as expected, even though all available pedals were used to generate current flow.As a result, the equipment was deemed non-functional.Despite multiple attempts by the physician and their team to remove the snare from around the polyp, they were unsuccessful.Eventually, they had to resort to cutting the flex wire and successfully removed the snare using a cold biopsy forceps.Some tissue was successfully removed as intended.The procedure was completed with a different device.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.Imdrf device code a150208 captures the reportable event of loop entrapment.Imdrf device code a050702 captures the reportable event of unable to cut.Block h10 investigation results: one captiflex snare was received for analysis.Visual and microscope analysis of the returned device found the working length and the wire were detached from the proximal section and the loop was bent.Electrical analysis cannot be performed due to the condition of the device.No other problems were noted.The reported events of "loop failure to cut" and "device failure to deliver energy could not be confirmed since the functional and electrical tests cannot be performed due to the condition of the device.The reported event of "loop entrapment of device" could not be confirmed since it is related to the procedure and could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Device analysis found that the working length and wire were detached 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.

• Brand Name: CAPTIFLEX
• 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: 17389225
• Report Number: 3005099803-2023-03936
• Device Sequence Number: 19779217
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• 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): 09/18/2023

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: 05/27/2025
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0029442612
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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