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

Model Number	M00562471
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of "spark shot out".Imdrf device code a0401 captures the reportable event of snare loop broken.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex extrasmall oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2023.According to the complainant, spark shot out during usage of device and the snare loop was broken.The procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of "spark shot out".Imdrf device code a0401 captures the reportable event of snare loop broken.Block h10: investigation results one captiflex snare was received for analysis.Visual and microscope analysis of the device noted that the loop was broken.In addition, the ends of the loop and the tip of the working length were blackened.No other device problems were noted.The reported event of loop break was confirmed since it was observed that the loop was broken, and the ends of the broken loop were blackened.This problem has occurred during procedure, and it is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device's performance and integrity.The loop break could have been generated if there was contact between the device and the scope during energization or the interaction with another medical device or tool during the procedure that can lead to break the loop as observed in the product analysis.Based on the analysis of the returned device and the information available, the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex extrasmall oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2023 according to the complainant, spark shot out during usage of device and the snare loop was broken.The procedure was completed.There were no patient complications reported as a result of this event.

• 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: 17557115
• Report Number: 3005099803-2023-04312
• Device Sequence Number: 4880307
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: 08714729019459
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 10/31/2023

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: 12/15/2025
• Device Model Number: M00562471
• Device Catalogue Number: 6247
• Device Lot Number: 0030727259
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown