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

Model Number	M00561191
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop break.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the loop wire was broken while performing hot polypectomy.The procedure was completed with another captivator snare device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the loop wire was broken while performing hot polypectomy.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 a0401 captures the reportable event of loop break.Block h11: the returned captivator snares was analyzed, and a visual and microscopic evaluation was performed, and it was found that the flare was detached from the working length (strain relief).Also, the device was checked under magnification, and it is important to mention that the working length had evidence of the flare being made.Additionally, it was found that the working length and wire were kinked at the proximal section.During analysis, it was found that the loop was not broken.No other problems with the device were noted.The reported event of loop break was not confirmed.It is likely that these problems occurred due to how the device was handled and manipulated, which may have caused the reported and encountered failures.Excessive manipulation of the device without enough care could have induced the defects found.Therefore, the most probable root cause of this complaint is adverse event related to procedure.

• 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; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20306827
• Report Number: 3005099803-2024-04697
• Device Sequence Number: 7588568
• Product Code: FDI
• UDI-Device Identifier: 08714729855934
• UDI-Public: 08714729855934
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/27/2024

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: 09/02/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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