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

Model Number	M00562321
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare fractured directly after it was unpacked.The procedure was completed with another new snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the reported (b)(6) health care facility.The reported health care facility's address is equipment section(b)(6).Block h6: imdrf device code a0401 captures the reportable event of snare loop break.
Additional Manufacturer Narrative
Block e1: the reported health care facility is yagami seisakusho co., ltd.Tokai product control center.The reported health care facility's address is(b)(6).Block h11: block b5 was updated to include additional information received on november 14, 2023.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare fractured directly after it was unpacked.The procedure was completed with another new snare.There were no patient complications reported as a result of this event.Additional information received on november 14, 2023* the sheath was broken, and it happened outside the patient.

• 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: 18105671
• Report Number: 3005099803-2023-06140
• Device Sequence Number: 20334500
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K202478
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 09/09/2025
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0030121658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• 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