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

Model Number	M00562451
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a captivator was used in a procedure performed on (b)(6) 2024.During the procedure, the active cord connection part was separated before usage.The procedure was completed with another captivator.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 was used in a procedure performed on (b)(6) 2024.During the procedure, the active cord connection part was separated before usage.The procedure was completed with another captivator.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.Block h10: the returned captivator snare device was analyzed, and a visual evaluation noted that the 2 in 1 connector was broken.No other problems with the device were noted.The reported event of cautery pin detachment of device or device component can be confirmed.Upon analysis of the 2 in 1 connector was detached from the cannula.The screw of the 2 in 1 connector was broken.However, based on the attached external form, the manufacturing process can ensure the correct component attachment, and the component work order does not have any variation, so it can be concluded that the failure mode could have been detected within the manufacturing process if it would have happened during it; therefore, the most probable root cause of this complaint is cause not established.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18993394
• Report Number: 3005099803-2024-01368
• Device Sequence Number: 15351011
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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