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

Model Number	M00562401
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used to remove a large (2cm) polyp in the sigmoid colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare cautery was set at 15 but when the physician attempted to cut the polyp the snare became stuck at the stalk of the polyp.It was reported that as the tech closed the snare, it felt like it was physically pushing back on her so she felt the tissue was thicker and the snare would not cut through the tissue.When they tried to reopen the snare, it felt stuck on the tissue.They turned up the cautery on the triad cautery machine and were able to cut the polyp but there was tissue damage left behind.The physician tried to clip the tissue damage but reported that the angle made it difficult.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• 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: 15324614
• Report Number: 3005099803-2022-04750
• Device Sequence Number: 5203881
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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 Expiration Date: 12/07/2024
• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0028494734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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