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

Model Number M00562451

Device Problem Failure to Deliver Energy (1211)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter facility name (b)(6) hospital.Block e1: initial reporter city (b)(6).Block h6: imdrf device code a090402 captures the reportable event of problem to deliver energy.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the sigmoid colon during an endoscopic colon polypectomy procedure performed on (b)(6) 2023.During the procedure and inside the patient, the snare was used to attempt to cut through a polyp; however, the snare did not generate any current.The snare was securely attached to the active cord and there was no problem noted with the cautery pin.There were no signs of blanching.The snare was removed from the patient and the procedure was completed with another captivator small hexagonal stiff snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the sigmoid colon during an endoscopic colon polypectomy procedure performed on (b)(6) 2023.During the procedure and inside the patient, the snare was used to attempt to cut through a polyp; however, the snare did not generate any current.The snare was securely attached to the active cord, and no problem was noted with the cautery pin.There were no signs of blanching.The snare was removed from the patient, and the procedure was completed with another captivator small hexagonal stiff snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: initial reporter facility name (b)(6) hospital.Block e1: initial reporter city (b)(6).Block h6: imdrf device code a090402 captures the reportable event of problem to deliver energy.Block h10: investigation results a captivator snare was received for analysis.Visual inspection of the returned device revealed no damages.Functional testing was performed, and the loop could extend and retract well.The 2 in 1 connector passed dimensional testing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of failure to deliver energy could not be confirmed since the device passed the electrical test.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no problems with the device during visual and functional test.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction to block g1 (mfr site facility name and mfr site address 2) the initial mdr.

• 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: 16946533
• MDR Text Key: 315390733
• Report Number: 3005099803-2023-02502
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0030313335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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