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

Model Number M00562301

Device Problem Failure to Cut (2587)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.

Event Description

It was reported to boston scientific corporation that a captivator snare was used in the rectum to remove polyps during a rectal polyp removal procedure performed on (b)(6) 2023.During the procedure and inside the patient, the snare wire did not cut smoothly.The specimen was damaged and could not be sent for testing.The snare was securely attached to the active cord.No visible problem was noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator snare was used in the rectum to remove polyps during a rectal polyp removal procedure performed on (b)(6) 2023.During the procedure and inside the patient, the snare wire did not cut smoothly.The specimen was damaged and could not be sent for testing.The snare was securely attached to the active cord.No visible problem was noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator snare was received for analysis.Visual inspection of the returned device revealed no problems.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, the loop could extend and retract well.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of loop failure to cut was unable to be confirmed since the device was returned without any failure on it, and after a functional test, the loop could extend and retract properly, and its electrical resistance was found within specifications.In addition, since the device cannot be functionally tested by emulating the anatomical/procedural factors encountered during the procedure the reported allegation cannot be confirmed.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint 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: 18405842
• MDR Text Key: 331721646
• Report Number: 3005099803-2023-06857
• Device Sequence Number: 1
• Product Code: FDI
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0030478779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 55 KG