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

Model Number M00562421

Device Problems Failure to Cut (2587); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a procedure performed on (b)(6) 2022.During the procedure, the snare loop was tightly coiled around the polyp with the active cable attached to the snare.The physician then used cautery to cut through the polyp and since it was a larger polyp, the snare had difficulty cutting the entire way through, so they decided to open up the snare and close it again.As they tried to pull the active cable off of the snare, the cautery pin was detached and stuck to the active cable.The original device was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code a0501 captures the reportable event of cautery pin detached imdrf device code a050702 captures the reportable event of polyp resecting issue investigation results: one captflex snare was received for analysis.Visual analysis of the returned device found no device problems however the 2 in 1 connector was found detached.Microscope test was completed and noted that the screw hat has one face flat.Xray test of the complaint device found the 2 in 1 connector as screw marks along the insert and the tip of the cannula.Media test of the complaint device found the 2 in 1 connector was detached and the pouch of the device.No other device problems were noted.The reported of "cautery pin detached" was confirmed since it was observed that the 2 in 1 connector was detached.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to the anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type, and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is cause not established.This code was selected since the investigation result did not lead to a clear conclusion about the case of the reported adverse event.

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a procedure performed on (b)(6) 2022.During the procedure, the snare loop was tightly coiled around the polyp with the active cable attached to the snare.The physician then used cautery to cut through the polyp and since it was a larger polyp, the snare had difficulty cutting the entire way through, so they decided to open up the snare and close it again.As they tried to pull the active cable off of the snare, the cautery pin was detached and stuck to the active cable.The original device was used to complete the procedure.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: 16039779
• MDR Text Key: 307031516
• Report Number: 3005099803-2022-07700
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019435
• UDI-Public: 08714729019435
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562421
• Device Catalogue Number: 6242
• Device Lot Number: 0030155347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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