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

Model Number	M00561191
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failure to deliver energy.
Event or Problem Description
Note: this report pertains to the one of three captivator snares that were used in the same procedure.It was reported to boston scientific corporation that three captivator snare were used during a polypectomy procedure performed on (b)(6) 2024.During the procedure, the device was inserted into the patient's body, but it could not be powered on.Additionally, the same problem occurred with the other two captivator snares.The procedure was completed with another captivator snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failure to deliver energy.Block h11 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device found the working length was bent at proximal section (strain relief).In the other hand, a continuity and electrical test were performed, and the device was found within specification.No other problems were noted.The reported event of "device failure to deliver energy" could not be confirmed.It was found that the working length was bent at proximal section (strain relief).It is likely that the procedural handling of the device could have contributed to the observed bent of the working length.The product analysis performed on the device it was found that the continuity and electrical test performed were found within specification.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.
Event or Problem Description
Note: this report pertains to the one of three captivator snares that were used in the same procedure.It was reported to boston scientific corporation that three captivator snare were used during a polypectomy procedure performed on (b)(6) 2024.During the procedure, the device was inserted into the patient's body, but it could not be powered on.Additionally, the same problem occurred with the other two captivator snares.The procedure was completed with another captivator snare device.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: 20118412
• Report Number: 3005099803-2024-04160
• Device Sequence Number: 15315131
• Product Code: FDI
• UDI-Device Identifier: 08714729855934
• UDI-Public: 08714729855934
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: M00561191
• Device Catalogue Number: 6119
• Device Lot Number: 0032892331
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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