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

Device Problems Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of loop cutting issue.

Event Description

Boston scientific corporation became aware of the following event through the article "effect of cold snare polypectomy for small colorectal polyps" written by qing qing meng, et.Al.The study was about the impact of cold snare polypectomy on small colorectal polyps.According to the literature, a study was conducted to compare the effectiveness and safety of cold snare polypectomy (csp) and hot snare polypectomy (hsp) for treating small colorectal polyps.Colorectal cancer is a significant healthcare challenge, and most cases are caused by intestinal polyps.Resection of these polyps has been shown to reduce the incidence of colorectal cancer.The study aimed to investigate the efficacy and safety of csp and hsp in this context.Event summary: it was reported that between january and december 2020, 301 patients with colorectal polyps ranging from 4-9 mm in diameter underwent endoscopic therapy.The patients were divided into two groups: csp (n = 154) and hsp (n = 147).The study compared various factors such as operating time, bleeding and perforation rates, use of titanium clips, and complete resection rate between the two groups.The findings revealed no significant differences in gender, age, and polyp characteristics between the csp and hsp groups.Both groups showed comparable resection rates, with csp at 93.4% and hsp at 94.5%.The use of titanium clips was significantly lower in the csp group (15.6%) compared to the hsp group (95.9%).Additionally, the csp group had a lower rate of delayed bleeding (0%) compared to the hsp group (2.0%), and a lower incidence of delayed perforation (0% versus 0.7%) compared to hsp.In conclusion, for sessile colorectal polyps smaller than 10 mm, csp demonstrated similar resection rates and tissue integrity compared to traditional hsp.Moreover, the csp group had a lower rate of complications, suggesting its safety and effectiveness for polypectomy.Note: no further information has been obtained despite good faith efforts.

Event Description

Boston scientific corporation became aware of the following event through the article "effect of cold snare polypectomy for small colorectal polyps" written by qing qing meng, et.Al.The study was about the impact of cold snare polypectomy on small colorectal polyps.According to the literature, a study was conducted to compare the effectiveness and safety of cold snare polypectomy (csp) and hot snare polypectomy (hsp) for treating small colorectal polyps.Colorectal cancer is a significant healthcare challenge, and most cases are caused by intestinal polyps.Resection of these polyps has been shown to reduce the incidence of colorectal cancer.The study aimed to investigate the efficacy and safety of csp and hsp in this context.Event summary: it was reported that between (b)(6) 2020, 301 patients with colorectal polyps ranging from 4-9 mm in diameter underwent endoscopic therapy.The patients were divided into two groups: csp (n = 154) and hsp (n = 147).The study compared various factors such as operating time, bleeding and perforation rates, use of titanium clips, and complete resection rate between the two groups.The findings revealed no significant differences in gender, age, and polyp characteristics between the csp and hsp groups.(b)(4).The use of titanium clips was significantly lower in the csp group (15.6%) compared to the hsp group (95.9%).Additionally, the csp group had a lower rate of delayed bleeding (0%) compared to the hsp group (2.0%), and a lower incidence of delayed perforation (0% versus 0.7%) compared to hsp.In conclusion, for sessile colorectal polyps smaller than 10 mm, csp demonstrated similar resection rates and tissue integrity compared to traditional hsp.Moreover, the csp group had a lower rate of complications, suggesting its safety and effectiveness for polypectomy.Note: no further information has been obtained despite good faith efforts.Correction june 15, 2023.This report was sent in error.As there is no reportable allegation against the device itself, boston scientific no longer considers this to be a reportable event.Please see report 3005099803-2023-03211 for information regarding this study.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: (initial reporter facility name).The second part of (b)(6).Block h11: correction to the initial mdr in block b5, block h1, and block h6.This report was sent in error.As there is no reportable allegation against the device itself, boston scientific no longer considers this to be a reportable event.Please see report 3005099803-2023-03211 for information regarding this study.

• Brand Name: CAPTIVATOR II
• 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: 17125886
• MDR Text Key: 317853980
• Report Number: 3005099803-2023-03164
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1