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

Model Number M00562391

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/21/2023

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 deliver energy.

Event Description

It was reported to boston scientific corporation that a captivator lg oval thin wire flex snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, the device was unable to generate electricity and could not effectively remove the polyps.The procedure was completed with a similar captivator lg oval thin wire flex 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 lg oval thin wire flex snare was used during a polypectomy procedure performed on (b)(6) 2023 during the procedure, the device was unable to generate electricity and could not effectively remove the polyps.The procedure was completed with a similar captivator lg oval thin wire flex 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 deliver energy.Block h10 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device found the working length was kinked in the middle section.Functional and electrical analysis found no device problems.No other problems were noted.The reported event of "device failure to deliver energy" could not be confirmed since no issues were noted with the electrical device testing during continuity test upon return.The reported event of "loop failure to cut " could not be confirmed since the device cannot be functionally evaluated with respect to the anatomical/procedural factors encountered during the procedure.Device analysis found working length was kinked while no issues with the device during functional and continuity test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.

• 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: 17689287
• MDR Text Key: 322708395
• Report Number: 3005099803-2023-04764
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202478
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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
• Device Lot Number: 0028494737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 65 KG