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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the following event through the article "cold versus hot emr for large duodenal adenomas" written by alessandro repici, et al.The retrospective study compared cold emr and hot emr in terms of safety and recurrence rates for the removal of large duodenal adenomas.According to the literature, 33 patients underwent cold emr for duodenal adenomas using a 10mm captivator ii, and 101 hot emr cases previously performed were retrospectively collected to provide comparative data.It was reported that a patient who underwent hot emr had a post procedural perforation requiring emergency surgery.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block e1 (initial reporter facility name) department of interdisciplinary endoscopy, university hospital hamburg-eppendorf.Block h6 imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf device code a24 captures the reportable event of adverse event without identified device or problem.

Event Description

Boston scientific corporation became aware of the following event through the article "cold versus hot emr for large duodenal adenomas" written by alessandro repici, et al.The retrospective study compared cold emr and hot emr in terms of safety and recurrence rates for the removal of large duodenal adenomas.According to the literature, 33 patients underwent cold emr for duodenal adenomas using a 10mm captivator ii, and 101 hot emr cases previously performed were retrospectively collected to provide comparative data.It was reported that a patient who underwent hot emr had a post procedural perforation requiring emergency surgery.Correction: this complaint was based off the journal article repici a, capogreco a, marco s, et al."cold versus hot emr for large duodenal adenomas." gut 2022; 71: 1763-1765.Upon further review of the article, there is no indication that the snares used in the hot emr cases associated with adverse events were boston scientific devices.The article reported that boston scientific snares were used in the cold emr cases and there were no reported complications associated with this group.The article did not identify the manufacturer(s) of the snares used during the hot emr cases.As a result, it was determined that the complaint was created in error as there is no evidence of any boston scientific device involvement in the adverse events associated with the hot emr cases.Boston scientific no longer considers this to be an incident against a boston scientific device and as such, no longer considers this to be a reportable event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block e1 (initial reporter facility name) (b)(4).Block g3: literature source repici a, capogreco a, marco s, et al."cold versus hot emr for large duodenal adenomas" gut 2022; 71: 1763-1765.Doi:10.1136/gutjnl-2022-327171.Block h10: this complaint was based off the journal article repici a, capogreco a, marco s, et al."cold versus hot emr for large duodenal adenomas." gut 2022; 71: 1763-1765.Upon further review of the article, there is no indication that the snares used in the hot emr cases associated with adverse events were boston scientific devices.The article reported that boston scientific snares were used in the cold emr cases and there were no reported complications associated with this group.The article did not identify the manufacturer(s) of the snares used during the hot emr cases.As a result, it was determined that the complaint was created in error as there is no evidence of any boston scientific device involvement in the adverse events associated with the hot emr cases.Boston scientific no longer considers this to be an incident against a boston scientific device and as such, no longer considers this to be a reportable event.Block h11: correction to block b1, block b2, block b5, block h1, block h6 and block h10 the initial mdr.

• 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: 17086028
• MDR Text Key: 316859619
• Report Number: 3005099803-2023-03079
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• 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
• Patient Outcome(s): Required Intervention