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

Model Number	M00562301
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.
Event or Problem Description
It was reported to boston scientific corporation that a captivator-snares was used in the colon to treat polyps during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was unable to completely snare the polyps, resulting in incomplete resection.The procedure was completed with another captivator-snares.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 captivator-snares was used in the colon to treat polyps during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was unable to completely snare the polyps, resulting in incomplete resection.The procedure was completed with another captivator-snares.There were no patient complications reported as a result of this event.Additional information received on march 25, 2025: it was reported that the section of the colon is the transverse colon.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.Block b5, section e have been updated based on the additional information received on march 25, 2025.

• Brand Name: CAPTIVATOR
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21758784
• Report Number: 3005099803-2025-01349
• Device Sequence Number: 20955008
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312(17)270206(10)33375845
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0033375845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 02/07/2024
• 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 Age: 54 YR
• Patient Sex: Male