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

Model Number	M00561291
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a polypectomy procedure performed on (b)(6) 2022.During the procedure, the device could not cut or deliver energy to remove the polyp.The snare was securely connected to the active cord.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a polypectomy procedure performed on (b)(6) 2022.During the procedure, the device could not cut or deliver energy to remove the polyp.The snare was securely connected to the active cord.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter address) (b)(6).Block h6: problem code a050702 captures the reportable event of polyp resecting issue; problem code a090402 captures the reportable event of energy generating issue.Block h10: investigation results a captivator extra large round stiff snare was received for analysis.Visual inspection of the returned device and active cord revealed no problems noted.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, it contracted and extended well.Dimensional inspected was performed and it was within of expect.And electrical inspection was also performed, and the device's electrical resistance was within specification, indicating a proper connection.No other device problems were noted.The reported event of "device failure to deliver energy" could not be confirmed since no issues were noted with the electrical device testing during continuity test upon return.The reported event of "loop failure to cut " could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this is not a new failure type, and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual, functional, dimensional and electrical test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.

• Brand Name: CAPTIVATOR II
• 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: 15721420
• Report Number: 3005099803-2022-06464
• Device Sequence Number: 15339051
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 07/29/2024
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0027758054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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