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

Model Number	M00562401
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snares device was used for polypectomy during a colonoscopy procedure performed on an unknown date.During the procedure, the handle piece started falling apart, and the cautery port metal fell out.The procedure was completed with another captiflex snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated to july 1, 2025, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snares device was used for polypectomy during a colonoscopy procedure performed on an unknown date.During the procedure, the handle piece started falling apart, and the cautery port metal fell out.The procedure was completed with another captiflex snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated to july 1, 2025, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.Block h11: the returned captiflex snare was analyzed, and a visual evaluation was performed, and it was noted that the cautery pin was detached from the handle.No other problems with the device were noted.Although the device met all required manufacturing specifications and passed all controls and inspections with no abnormalities reported during the assembly process, the visual inspection of the returned unit confirmed the detachment issue.Boston scientific has initiated an investigation to further evaluate snare loops unable to cut events to determine the root cause of these events, as well as appropriate mitigation(s).Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.Block h11: block e1 (initial reporter title) has been corrected.
Additional Manufacturer Narrative
Block h2: additional information: block e1 (initial reporter email) has been updated based on the additional information received on january 5, 2026.Block b3: approximated to july 1, 2025, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snares device was used for polypectomy during a colonoscopy procedure performed on an unknown date.During the procedure, the handle piece started falling apart, and the cautery port metal fell out.The procedure was completed with another captiflex snare device.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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22699374
• Report Number: 3005099803-2025-03804
• Device Sequence Number: 9150285
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: (01)08714729019411(17)270829(10)34744883
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K202478
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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 Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0034744883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 01/05/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/03/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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