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

Model Number	M00562341
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01845 for the first captivator, and 3005099803-2024-01844 for the second captivator.It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used for cancer detection during a colonoscopy - polypectomy procedure performed on (b)(6) 2024.During the procedure, it was noticed that the hot cautery was not firing well.It was unsure if the physician was using a cut or a coagulation.The case was also large.The case also had a large polyp, which took up two jars and was most likely cancerous.The snare loop did not extend completely and had issues with cautery.The procedure was completed with a different boston scientific snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h11: block b5 (event description) has been corrected.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01845 for the first captivator, and 3005099803-2024-01844 for the second captivator.It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the colon for cancer detection during a colonoscopy - polypectomy procedure performed on (b)(6) 2024.During the procedure, a 27 mm snare was attempted to use for removing a large polypoid mass that appeared to be pedunculated measuring about 3 cm in size.The snare was securely attached to active cord and no problems were noted with the cautery pin.However, the snare cautery did not work and would not cut through the base of the polyp.They used another 27 mm snare to cut the polyp, but the cautery still did not work.They had to use a 13 mm hot snare to remove the polyp tissue into a piecemeal size that took up two jars to remove using a roth net.There was difficulty removing the polypoid mass as it appeared to have a fibrotic base.They then used cold snare polypectomy to remove most of the fibrotic tissue base concerning for neoplasm.Therefore, they placed a tattoo that was 1-fold upstream and 1-fold downstream from the mass.The procedure was completed with a different captivator snare.There were no patient complications reported as a result of this event.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19202366
• Report Number: 3005099803-2024-01845
• Device Sequence Number: 20845321
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: M00562341
• Device Catalogue Number: 6234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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