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

Model Number M00561223

Device Problem Failure to Deliver Energy (1211)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.

Event Description

It was reported to boston scientific corporation that a captivator ii snare was used in the colon to remove polyps during a colonoscopy-polypectomy procedure performed on an unknown date.During the procedure, there was no cautery.The cable was securely attached to the snare and the cable was changed out but there was no heat.There was no problem noted with the cautery pin.The snare was disengaged from the polyp and a non-bsc device was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h10: investigation results: a captivator ii snare was received for analysis.Visual and microscopic inspection of the returned device revealed no problems had been noted.Electrical testing was performed, and the device was found within specification.No other 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.Upon product analysis, no problems were noted.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 captivator ii snare was used in the colon to remove polyps during a colonoscopy-polypectomy procedure performed on an unknown date.During the procedure, there was no cautery.The cable was securely attached to the snare and the cable was changed out but there was no heat.There was no problem noted with the cautery pin.The snare was disengaged from the polyp and a non-bsc device was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR II
• 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: 18669467
• MDR Text Key: 336189153
• Report Number: 3005099803-2024-00301
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861317
• UDI-Public: 08714729861317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• 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: 03/14/2024

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: M00561223
• Device Catalogue Number: 50297
• Device Lot Number: 0031650026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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