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

Device Problem Failure to Cut (2587)

Patient Problem Perforation (2001)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf device code a050702 captures the reportable event of loop unable to cut.

Event Description

It was reported to boston scientific corporation that a captivator ii snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician used the snare to resect a flat polyp, however a small amount of tissue still present after the partial resection.To get rid of the remaining tissue, the physician used hot snaring procedure, however it resulted to perforation and needed an ileosectomy procedure to resolve.Subsequently, the patient recovered.According to the nurse manager, the physician thinks that the combination of snaring and subsequent heating caused the perforation.The procedure was completed with the original device.The patient's condition at the conclusion of the procedure was reported to be recovered.

• 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: 16954237
• MDR Text Key: 315481542
• Report Number: 3005099803-2023-02620
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White