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

Model Number	M00561233
Medical Device Problem Codes	Failure to Deliver Energy (1211); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to 01/01/2025 as the event date is unknown.Block h6: imdrf device code a090402 captures the reportable event of loop failure to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used for a procedure performed on an unknown date.During the procedure, there was an ongoing issue with the snare, particularly with fully extending it from the sheath.They also mentioned that the cautery was not able to work consistently with the snare.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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21312697
• Report Number: 3005099803-2025-00300
• Device Sequence Number: 15679467
• Product Code: FDI
• UDI-Device Identifier: 08714729861348
• UDI-Public: 08714729861348
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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: 0034894212
• 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: 01/14/2025
• Initial Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 09/20/2024
• 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