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

Model Number	M00561233
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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the date of the event was approximated to 4/1/2025 based on the date the manufacturer became aware of the event.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of the cautery pin being detached.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii 15 mm rounded stiff snare was used during a polypectomy procedure performed on an unknown date.During the procedure, the snare was disconnected from the handle.There were no patient complications reported as a result of this event.No further information has been obtained despite good-faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii 15 mm rounded stiff snare was used during a polypectomy procedure performed on an unknown date.During the procedure, the snare was disconnected from the handle.There were no patient complications reported as a result of this event.Additional information received on may 14, 2025: the procedure was completed with another captivator ii 15 mm rounded stiff snare.
Additional Manufacturer Narrative
Block b3: the date of the event was approximated to (b)(6) 2025 based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of the cautery pin being detached.Block h2 (additional information): block b5, block d3 (model number, lot number, catalog number) and block d4 (expiration date and unique identifier (udi) #) have been updated based on the additional information received on may 14, 2025.

• 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: 21969451
• Report Number: 3005099803-2025-02070
• Device Sequence Number: 12887529
• Product Code: FDI
• UDI-Device Identifier: 08714729861348
• UDI-Public: (01)08714729861348(17)271015(10)35069972
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: M00561233
• Device Catalogue Number: 50297
• Device Lot Number: 0035069972
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 10/15/2024
• 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