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

Model Number	M00562631
Medical Device Problem Codes	Failure to Cut (2587); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned profile was analyzed, and a visual evaluation noted that the wire was kinked and the working length was ripped, torn and kinked making it impossible to extend and retract the loop.A continuity test was performed, and the device passed since the device's electrical resistance was within specification.No other issues with the device were noted.The reported events of loop failure to cut and wire kinked were confirmed.The investigation also found the working length to be ripped, torn and kinked.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Upon product analysis it was observed that the wire was kinked and the working length was ripped, torn and kinked.These types of failures could get damage during its manipulation.Most likely procedural factors as handling the device, the technique used by the physician during initial use, set-up, power-up, or shortly thereafter could have affected its performance and its intended purpose, leading to the reported event.Based on the information available and the analysis of the returned device, the code selected as the most probable complaint cause is adverse event related to the procedure.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 profile was used during a polypectomy procedure performed on (b)(6) 2021.During the procedure, after excising three polyps without energization, when strangulating the fourth one, it was unable to cut at all.When the snare was removed from the endoscope and checked, it was reported that the wire was bent, and the procedure could not be completed with that snare.The procedure was completed with another profile.There were no patient complications reported as a result of this event.

• Brand Name: PROFILE
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11404121
• Report Number: 3005099803-2021-00788
• Device Sequence Number: 20023626
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: 08714729156628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: 10/06/2023
• Device Model Number: M00562631
• Device Catalogue Number: 6253
• Device Lot Number: 0026131072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1