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

Model Number	M00562341
Medical Device Problem Codes	Failure to Deliver Energy (1211); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6)2022.During the procedure, the snare was loosely connected to the cautery cord and needed to be held in place.The circuit showed complete on the generators, the circuit was green, but cautery was not being delivered through the snare.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code a090402 captures the reportable event of snare unable to deliver energy.Block h10: (product investigation): one captivator snare was received for analysis.Visual analysis of the device did not find any problems.Microscopic inspection noted that the 2 in 1 connector did not find any problems.Functional testing was performed, and the device was able to connect with a boston scientific corporation active cord and two non-bsc active cords.Electrical testing was performed, and the device's electrical resistance was within specification.The 2 in 1 component also passed dimensional testing.No other problems were noted.The reported event of device failed to deliver energy could not be confirmed.During product analysis the device was connected with three different cables and no problems were noted.Additionally, the device passed electrical testing and the 2 in 1 connector passed dimensional testing.Based on the analysis of the returned device and the information available, the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the snare was loosely connected to the cautery cord and needed to be held in place.The circuit showed complete on the generators, the circuit was green, but cautery was not being delivered through the snare.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR
• Common Device Name: 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: 15476069
• Report Number: 3005099803-2022-05531
• Device Sequence Number: 14953855
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0024564272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown