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

Model Number	M00562341
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the esophagus to treat varicose bleeding during an esophageal varices procedure performed on (b)(6) 2025.During the procedure, the snare loop detached from the device, and the handle cannula broke.The detached piece was retrieved using foreign body forceps, and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event and the patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of snare loop detached that was retrieved using foreign body forceps.

• 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: 21762360
• Report Number: 3005099803-2025-01355
• Device Sequence Number: 8455839
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: (01)08714729019350(17)251125(10)30603739
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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 Expiration Date: 11/25/2025
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0030603739
• 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: 03/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 11/26/2022
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 58 KG