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

Model Number M00562391

Device Problems Failure to Cut (2587); Positioning Problem (3009)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the suspect device lot number was not available; therefore, the manufacture and expiration dates are unknown.Block e1: (initial reporter city) (b)(6).Block h6: imdrf device code a050702 captures the reportable event of loop cutting issue.

Event Description

Note: this manufacturer report pertains to one of three devices used in the same procedure.Refer to manufacturer report # 3005099803-2023-04401, 3005099803-2023-04402, for the other associated device information.It was reported to boston scientific corporation that a captivator medium oval stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, there was difficulty in accurately positioning the snare loop around a one centimeter polyp in the transverse and sigmoid colon.As a result, the snare was unable to fully cut the polyp, leading to an incomplete incision.However, there was no perforation.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.

Event Description

Note: this manufacturer report pertains to one of three devices used in the same procedure.Refer to manufacturer report # 3005099803-2023-04401, 3005099803-2023-04402 and 3005099803-2023-04403 for the other associated device information.It was reported to boston scientific corporation that a captivator medium oval stiff snare was used during a polypectomy procedure performed on (b)(6), 2023.During the procedure, there was difficulty in accurately positioning the snare loop around a one centimeter polyp in the transverse and sigmoid colon.As a result, the snare was unable to fully cut the polyp, leading to an incomplete incision.However, there was no perforation.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the suspect device lot number was not available; therefore, the manufacture and expiration dates are unknown.Block e1: (initial reporter city) (b)(6).Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Block h11: block g2 report source (other) has been corrected.Block h6 (patient code) has been corrected.Block h6 (device code) has been corrected.

• 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: 17548123
• MDR Text Key: 321427396
• Report Number: 3005099803-2023-04403
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019404
• UDI-Public: 08714729019404
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562391
• Device Catalogue Number: 6239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/25/2023
• 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 Age: 70 YR
• Patient Sex: Female