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	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported health care facility's address is (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, when trying to resect the mucosa the snare could not be energized by high frequency.The snare was securely attached to the active cord but the snare couldn't deliver energy at all.The procedure was completed with the original device by cold polypectomy.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the reported health care facility's address is (b)(6) prefecture 2320024.Block h6: problem code (b)(6)captures the reportable event of snare could not 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 problems had been found.Functional testing was performed, and the loop could extend and retract well.The 2 in 1 connector passed dimensional testing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.Device analysis found no problems with the device.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 complaint cannot be confirmed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6), 2022.During the procedure and inside the patient, when trying to resect the mucosa the snare could not be energized by high frequency.The snare was securely attached to the active cord but the snare couldn't deliver energy at all.The procedure was completed with the original device by cold polypectomy.There were no patient complications reported as a result of this event.

• 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 CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15487273
• Report Number: 3005099803-2022-05494
• Device Sequence Number: 13952158
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: 08714729855927
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 04/17/2025
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0029190911
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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