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

Model Number	M00561311
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a090402 captures the reportable event of device could not deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, in an attempt to use esu with the snare, the esu did not work.They used a hot biopsy forceps and it worked.It was not reported what device was used to complete the procedure.It was not reported if 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 device could not deliver energy block h10: (product investigation): one captivator snare was received for analysis.There were no issues noted during visual analysis.The 2 in 1 connector was dimensionally inspected and was found to be within specification.Electrical testing was performed, and the device's electrical resistance was within specification.No other device problems were noted.The reported event of "device failed to deliver energy" could not be confirmed.Electrical testing was performed during product analysis and the device's electrical resistance was found to be within specification.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected since the reported event could not be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, in an attempt to use esu with the snare, the esu did not work.They used a hot biopsy forceps and it worked.It was not reported what device was used to complete the procedure.It was not reported if 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 device could not deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, in an attempt to use esu with the snare, the esu did not work.They used a hot biopsy forceps and it worked.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.

• 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: 16576355
• Report Number: 3005099803-2023-01432
• Device Sequence Number: 20622773
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2023

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: 11/29/2025
• Device Model Number: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0030623220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 04/18/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/06/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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