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

Model Number	M00562402
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
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
It was reported to boston scientific corporation that a captiflex was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the doctor attempted to remove a polyp with the snare to which the snare would not power to cut through the polyp.The procedure was completed with another 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 loop failure to cut.Block h10: the returned captiflex was analyzed, and a visual evaluation noted that the cautery pin prongs were closed.A functional evaluation was done through an active cord gauge (go/ no go) test and the device failed due to the cautery pin prongs being closed.A continuity test was done and the device passed since the device's electrical resistance was within specification.No other issues with the device were noted.The reported event of device failure to deliver energy was unable to be confirmed since the device passed the continuity test upon return even with the damage encountered.The reported event of loop failure to cut was unable to be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.During product analysis it was found that the cautery pin prongs were closed.Based on the information available and the analysis of the returned device, the code selected as the most probable complaint cause is manufacturing deficiency.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the doctor attempted to remove a polyp with the snare to which the snare would not power to cut through the polyp.The procedure was completed with another snare.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
• MDR Report Key: 11507133
• Report Number: 3005099803-2021-01105
• Device Sequence Number: 11457345
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 05/01/2021
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0022067883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1