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

Model Number M00562301

Device Problems Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, while opening the snare loop, a residual piece of plastic was found in the snare, preventing the snare from opening and making the device unusable.The procedure was completed with a different larger diameter 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 oval stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, while opening the snare loop, a residual piece of plastic was found in the snare, preventing the snare from opening and making the device unusable.The procedure was completed with a different larger diameter snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.Block h10 investigation results: one captivator snare was received for analysis.Visual and microscope analysis of the returned device found the working length and loop has foreign matter.The foreign matter was analyzed and it was a type of polyester that was different from the polyester used in the tubing.This suggests that the foreign material came from an external source, rather than being part of the manufacturing process.No other device problems were noted.The reported event of "device foreign material present in device" is confirmed since foreign matter was found in the working length and loop.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 foreign matter in the working length and loop device during visual and microscope test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is cause not established.This code was selected since the event did not lead to a clear conclusion about the cause of the reported adverse event.An investigation is in place to address this problem.

• 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: 17119183
• MDR Text Key: 317850855
• Report Number: 3005099803-2023-02815
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0029106164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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