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

Model Number	M00562321
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium oval stiff snare was used to resect a 0.6cm polyp in the descending colon during an intestinal polyp removal procedure performed on (b)(6) 2023.During the procedure, there was a problem with the electric snare's closure when it was tightened.It was not possible to completely remove the polyp, and there was excessive burning of the surrounding intestinal mucosa.The procedure was completed with a similar captivator medium oval stiff snare.There no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the suspect device lot number was not reported; therefore, the manufacture and expiration dates are unknown.Block e1: (initial reporter city) (b)(6).Block h6: imdrf device code a050702 captures the reportable event of loop cutting problems.
Additional Manufacturer Narrative
Block d4, h4: the suspect device lot number was not reported; however additional information received on july 4, 2023 stating the manufacture date was june 6, 2022 and the expiration date is on june 6, 2025.Block e1: (initial reporter city) (b)(6).Block h6: imdrf device code a050702 captures the reportable event of loop cutting problems.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium oval stiff snare was used to resect a 0.6cm polyp in the descending colon during an intestinal polyp removal procedure performed on (b)(6) 2023.During the procedure, there was a problem with the electric snare's closure when it was tightened.It was not possible to completely remove the polyp, and there was excessive burning of the surrounding intestinal mucosa.The procedure was completed with a similar captivator medium oval stiff snare.There 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: 17243156
• Report Number: 3005099803-2023-03478
• Device Sequence Number: 6840892
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131700
• 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): 07/20/2023

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: M00562321
• Device Catalogue Number: 6232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/20/2023
• 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