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

Model Number	M00562341
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-01658 and 3005099803-2022-01793 for the associated device information.It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large colon polyp during a colonoscopy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, the first snare stopped cauterizing within a few seconds.They changed the erbe and it still did not work even though the cord was correctly on tight with no visible issue in the cautery pin.A second snare was used and removed the polyp.It was reported that the patient had a perforation.A ct was done and the physician reported the perforation barely went through the serosa.The physician clipped the perforation and the patient was fine the next day.The patient did not report any pain the next day.In the physician's assessment the perforation was not related to the first device and occurred because the technician was opening and closing the second device multiple times as the physician was cauterizing and the tip of the hexagonal snare was hitting the lumen each time.Refer to manufacturer report # 3005099803-2022-01793 for the information on the second device and perforation.
Additional Manufacturer Narrative
Block h6: problem code a07 captures the reportable event of device delivers energy intermittently.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed no problems had been noted.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.As per media inspection, the customer provided a photo where the device was inside the original opened pouch and no problems was noted.No other problems were noted.The reported event of device failure to deliver energy was not confirmed since no problems were noted with the electrical device testing during test upon return.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.In addition, based on the information reported the device was used after the expiration date and it is important to mention that the integrity and functionality of the device could not be ensured if the device was used after this date as mentioned in the instructions for use (ifu) of the device.Based on the information provided and analysis of the returned device, the most probable cause for the reported event is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was not used per the instructions for use (ifu) / product label as the device was used after its expiration date.
Event or Problem Description
Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-01658 and 3005099803-2022-01793 for the associated device information.It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large colon polyp during a colonoscopy procedure performed on (b)(6), 2022.It was reported that during the procedure and inside the patient, the first snare stopped cauterizing within a few seconds.They changed the erbe and it still did not work even though the cord was correctly on tight with no visible issue in the cautery pin.A second snare was used and removed the polyp.It was reported that the patient had a perforation.A ct was done and the physician reported the perforation barely went through the serosa.The physician clipped the perforation and the patient was fine the next day.The patient did not report any pain the next day.In the physician's assessment the perforation was not related to the first device and occurred because the technician was opening and closing the second device multiple times as the physician was cauterizing and the tip of the hexagonal snare was hitting the lumen each time.Refer to manufacturer report # 3005099803-2022-01793 for the information on the second device and perforation.

• 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: 14046169
• Report Number: 3005099803-2022-01658
• Device Sequence Number: 14867043
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/26/2022

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: 01/10/2022
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0023174747
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female