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

Model Number M00562401

Device Problems Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/01/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 302839033
• Report Number: 3005099803-2022-04750
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1