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

Model Number	M00562402
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on an unknown date.During the procedure, the snare had difficulty cutting through the tissue when resecting a polyp.The procedure was reported to be completed; however, it was not reported what device was used to complete the procedure.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
The exact date of the event is unknown.The provided event date of (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Problem code: (b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 13908644
• Report Number: 3005099803-2022-01398
• Device Sequence Number: 19804144
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 03/24/2022

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: 04/06/2024
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0027085177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2021
• 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