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

Model Number	M00562451
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop break.
Event or Problem Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, threaded the snare through the scope and opened it to capture a polyp.When attempted to close the snare around the polyp, they heard and felt a snap.It was unable to close to remove the polyp from the scope, so pulled the snare out while it was still open.The procedure was completed with another captivator small hexagonal stiff snare device.There were no patient complications reported as a result of this event.No further information has been obtained despite good-faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, threaded the snare through the scope and opened it to capture a polyp.When attempted to close the snare around the polyp, they heard and felt a snap.It was unable to close to remove the polyp from the scope, so pulled the snare out while it was still open.The procedure was completed with another captivator small hexagonal stiff snare device.There were no patient complications reported as a result of this event.Additional information received on november 12, 2024: the anatomy location is colon.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop break.Block h2 (additional information): block b5 has been updated based on the additional information received on november 12, 2024.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20614883
• Report Number: 3005099803-2024-05623
• Device Sequence Number: 7534582
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0033840564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 04/17/2024
• 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: Prefer Not To Disclose