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

Model Number	M00562371
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	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Problem code: (b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium crescent stiff snare was used for resection of polyp in the stomach during a polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, the snare failed to deliver energy after it was securely attached to the erbe and active cord.There were no visible problems found in the cautery pins of the device.All was connected but the snare would not cut with energy.They attempted to cold cut the polyp but there were no signs of cautery.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 medium crescent stiff snare was used for resection of polyp in the stomach during a polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, the snare failed to deliver energy after it was securely attached to the erbe and active cord.There were no visible problems found in the cautery pins of the device.All was connected but the snare would not cut with energy.They attempted to cold cut the polyp but there were no signs of cautery.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 a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator medium crescent stiff snare was received for analysis.Visual inspection of the returned device revealed that the loop, wire and working length were kinked.Functional inspection was performed and when the device was connected to the 10 inch loop fixture, it contracted and extended well.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "device failure to deliver energy" was not confirmed since the device passed when electrical test was performed.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem (the electrical test passed), design or user problem which could have caused the complaint.Upon product analysis it was observed that the loop, wire and working length were kinked.These types of problems could occur during its manipulation.Most likely this was caused by procedural factors as handling of the device, the technique used by the physician during initial use, set-up, power-up, or procedure, therefore, the observations of loop, wire, and working length being kinked were coded as "adverse event related to procedure".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 event could not be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 13654010
• Report Number: 3005099803-2022-00968
• Device Sequence Number: 17635752
• Product Code: FDI
• UDI-Device Identifier: 08714729019381
• UDI-Public: 08714729019381
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/29/2022

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: 04/26/2022
• Device Model Number: M00562371
• Device Catalogue Number: 6237
• Device Lot Number: 0023698108
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2019
• 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