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

Model Number	M00562471
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during a polypectomy procedure performed on an unknown date.During the procedure, he doctors have noticed that when they use hot snares, they are not cutting through tissue as effectively as expected.They have tried adjusting their generator settings, but they have consistently observed this issue across different batches of snares and various types of snare families.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 b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the suspect device upn and lot number is not reported; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a050702 captures the reportable event of loop cutting issue.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop cutting issue.Block b5 has been updated based on additional information received august 11, 2023.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during a polypectomy procedure performed on an unknown date.During the procedure, the doctors noticed that when they use hot snares, they are not cutting through tissue as effectively as expected.They have tried adjusting their generator settings, but they have consistently observed this issue across different batches of snares and various types of snare families.It was not reported what device was used to complete the procedure.It is not known if there were any patient complications reported as a result of this event.Additional information received on august 11, 2023 : during the procedure performed on (b)(6) 2023, the physician removed a polyp using a snare but noticed that the center of the polyp remained after the procedure.The procedure was reported to be completed with a non-bsc device.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• 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: 17481949
• Report Number: 3005099803-2023-04220
• Device Sequence Number: 7181863
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: 08714729019459
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 02/02/2026
• Device Model Number: M00562471
• Device Catalogue Number: 6247
• Device Lot Number: 0030986207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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