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

Model Number	M00562301
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: the reported health care facility is (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6), 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.Block h11: blocks a2 (age at time of event) has been updated based on corrected information received on february 7, 2024.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.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: 18180550
• Report Number: 3005099803-2023-06174
• Device Sequence Number: 15366973
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0029153505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male