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

Model Number	M00561241
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii was used in the colon during an endoscopic colorectal polyp resection procedure performed on (b)(6) 2025.During the procedure, an energization was unable to perform.The procedure was completed with another captivator ii.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a090402 captures the reportable event of energy generating problem.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a090402 captures the reportable event of energy generating problem.Block h11: the returned captivator ii snare was analyzed, and the device was returned and visually inspected, with no visible damage found.Electrical testing was performed, and the device was within specification and showed proper continuity.Finally, the device was tested with the erbe (bsc0077509), and the erbe had no issues supplying energy to the snare.No other problems with the device were noted.The reported event of energy generating problem was not confirmed.Upon analysis, the device showed no visible damage.It underwent continuity and electrical testing and was found to be within specification.The device was also tested with the erbe (bsc0077509), which had no issues supplying energy to the snare.Therefore, the most probable root cause of this complaint is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii was used in the colon during an endoscopic colorectal polyp resection procedure performed on (b)(6) 2025.During the procedure, an energization was unable to perform.The procedure was completed with another captivator ii.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21857589
• Report Number: 3005099803-2025-01665
• Device Sequence Number: 12741763
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: (01)08714729855927
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133987
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: M00561241
• Device Catalogue Number: 6124
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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