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

Model Number M00562471

Device Problems Failure to Deliver Energy (1211); Mechanical Problem (1384)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captiflex snare was used during a gastrointestinal procedure performed on (b)(6) 2023.During preparation, the cautery of the device was not working.No problem was noted with the handle of the device.The procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h10: investigation results one captiflex 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 without any problem.Electrical testing was performed, and the device was found within specification.No other device problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.The reported complaint of loop failure to extend was unable to be confirmed since the loop could extend completely.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.

Event Description

It was reported to boston scientific corporation that a captiflex snare was used during a gastrointestinal procedure performed on (b)(6) 2023.During preparation, the cautery of the device was not working.No problem was noted with the handle of the device.The procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• 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: 18161030
• MDR Text Key: 328416539
• Report Number: 3005099803-2023-06266
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: 08714729019459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562471
• Device Catalogue Number: 6247
• Device Lot Number: 0031468613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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