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	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Manufacturer report # 3005099803-2021-05432 for the associated device information.It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used for polyp removal during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the snare was unable to cut through the target polyp.A second captiflex snare was also unable to cut through the target polyp.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-05432 for the associated device information.It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used for polyp removal during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the snare was unable to cut through the target polyp.A second captiflex snare was also unable to cut through the target polyp.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code a050702 captures the reportable event of snare loop unable to cut.Block h10: investigation results a captiflex medium oval flexible snare was received for analysis.Visual inspection of the returned device revealed that the device was free of obvious kinks and bends, no problems with the cautery pin.No visual problems were noted.Functional inspection was performed and when the device was placed on the 10 inch loop fixture and the mechanism was actuated and the loop was able to extend and retract without any problems.Electrical test was performed and the device passed.No other problems were noted.The reported event of "loop failure to cut" was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.There were no device problems found during visual, functional, and electrical inspection.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.This code was chosen since the reported event cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 12675239
• Report Number: 3005099803-2021-05433
• Device Sequence Number: 13780380
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: 01/28/2023
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025111007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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