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

Model Number	M00562571
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 profile medium oval flexible snare was used during a procedure performed on (b)(6) 2023.During the procedure, the device has no electrical current detected.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block e1: (initial reporter address (b)(6).Imdrf device code a090402 captures the reportable event of device could not deliver energy block h10: investigation results a profile snare was received for analysis.Visual analysis of the returned device found that the handle part was not returned, the wire had a mechanical cut and the working length was melted and burnt indicating there was cauterization during the procedure which were also noted during microscope inspection.Electrical testing could not be performed due to the condition of the device.The reported event of unable to cauterize and/or apply electrical current was not confirmed.The analysis of the returned device showed that the working length was melted and blackened at the distal end, indicating there was cauterization during the procedure.Most likely, procedural factors such as the handling of the device and the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and led to the reported event.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a profile medium oval flexible snare was used during a procedure performed on (b)(6) 2023.During the procedure, the device has no electrical current detected.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: PROFILE
• 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: 16751480
• Report Number: 3005099803-2023-01776
• Device Sequence Number: 11579432
• Product Code: FDI
• UDI-Device Identifier: 08714729156635
• UDI-Public: 08714729156635
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/03/2023

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: 09/07/2024
• Device Model Number: M00562571
• Device Catalogue Number: 6257
• Device Lot Number: 0027965225
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown