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	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of unable to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used for polyps in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During the procedure, the snare was unable to deliver energy.The procedure was completed with another captivator ii 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 ii snare was used for polyps in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During the procedure, the snare was unable to deliver energy.The procedure was completed with another captivator ii snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of unable to deliver energy.Block h11: the returned captivator ii was analyzed, and a visual evaluation noted that the working length and wire were kinked at proximal section (strain relief).Additionally, a continuity and electrical test were performed, and the device was found within specification.No other problems with the device were noted.The reported event of device unable to deliver energy was not confirmed.Upon analysis, the working length and wire were kinked at proximal section (strain relief).Also, the continuity and electrical tests were found within specification.Since there is not enough evidence to determine that the reported event occurs due to a device problem.Therefore, the most probable root cause of this complaint 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20775739
• Report Number: 3005099803-2024-05999
• Device Sequence Number: 15488242
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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 Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0034050523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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