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

Model Number	M00561291
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (initial reporter facility name) the reported health care facility is the second affiliated (b)(6).Block h6: imdrf device code a150208 captures the reportable event of snare loop entrapment.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the transverse colon to remove multiple broad-based polyps measuring 4-5 mm during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, it was observed that the front end of the snare component was difficult to eject and became stuck, preventing it from moving freely in and out.This problem affected the performance of the polyp resection.The endoscopic polyp resection was conducted under endoscopic guidance, requiring the device to operate with precision and freedom.It was also reported that given the fragility of the intestinal mucosa, a stuck operating end could hinder timely retraction and potentially damage normal intestinal mucosa.After the device was replaced, the polyp resection procedure was successfully continued.The procedure was completed with another device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1: (initial reporter facility name) the reported health care facility is (b)(6).Blocks b5 and h6 (impact codes and device codes) have been updated based on the additional information received on august 26, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the transverse colon to remove multiple broad-based polyps measuring 4-5 mm during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, it was observed that the front end of the snare component was difficult to eject and became stuck, preventing it from moving freely in and out.This problem affected the performance of the polyp resection.The endoscopic polyp resection was conducted under endoscopic guidance, requiring the device to operate with precision and freedom.It was also reported that given the fragility of the intestinal mucosa, a stuck operating end could hinder timely retraction and potentially damage normal intestinal mucosa.After the device was replaced, the polyp resection procedure was successfully continued.The procedure was completed with another device.There were no patient complications reported as a result of this event.Additional information was received on august 26, 2025.The device was used to remove sessile flat polyps.There was no damage to the tissue.The snare device was unable to fully extend the loop.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22868206
• Report Number: 3005099803-2025-04186
• Device Sequence Number: 7650309
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: (01)08714729645801(17)270925(10)34930861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0034930861
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 09/25/2024
• 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: 56 YR
• Patient Sex: Male