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

Model Number M00562301

Device Problem Failure to Cut (2587)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

Block e1: the reported health care facility is (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.

Event Description

It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6), 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.Block h11: blocks a2 (age at time of event) has been updated based on corrected information received on february 7, 2024.

Event Description

It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR
• 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: 18180550
• MDR Text Key: 328613104
• Report Number: 3005099803-2023-06174
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0029153505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male