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

Model Number M00562451

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Imdrf device code a090402 captures the reportable event of unable to generate energy.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a polypectomy procedure performed on (b)(6) , 2023.During the procedure, the snare was unable to remove the polyp because it did not receive enough power.The device was properly connected to the generator, and the ablation pin was not damaged or bent.There were no signs of polyp blanching.The procedure was completed with a similar captivator small hexagonal stiff snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Imdrf device code a090402 captures the reportable event of unable to generate energy.Block h10 investigation results: one captivator snare was received for analysis.Visual, functional and electrical analysis of the returned device found no device problems.No other problems were noted.The reported events of "loop failure to cut" and "device failure to deliver energy could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual, functional and electrical test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected.This code was selected since the reported event could not be confirmed.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, the snare was unable to remove the polyp because it did not receive enough power.The device was properly connected to the generator, and the ablation pin was not damaged or bent.There were no signs of polyp blanching.The procedure was completed with a similar captivator small hexagonal stiff snare.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: 18022308
• MDR Text Key: 326744145
• Report Number: 3005099803-2023-05678
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 0031339627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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