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

Model Number	M00561241
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used in the rectum during a endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device was connected securely to the active cord but could not be electrified.No visible problem was noted with the cautery pin.There was no attempt to cold cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
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
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used in the rectum during a endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device was connected securely to the active cord but could not be electrified.No visible problem was noted with the cautery pin.There was no attempt to cold cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code (b)(6)captures the reportable event of device unable to deliver energy.Block h10: investigation results a captivator ii-20mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no damages found on the snare and active cord.Dimensional test was performed and the 2 in 1 was compared with the go no go fixture (active cord gauge) and it was within of expect.Continuity and electrical test were performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of device failure to deliver energy could not be confirmed since the device was found within specifications during electrical test and no damages were found.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected as the reported event of device failure to deliver energy could not be confirmed through product analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 14874716
• Report Number: 3005099803-2022-03457
• Device Sequence Number: 20256411
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: 08714729855927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133987
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 05/16/2024
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0027312018
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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 Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 50 KG