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

Model Number	M00562531
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The reported health care facility's address is (b)(6).Problem code (b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a profile extra small oval flexible snare was used to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on an unknown date.During the procedure and inside the patient, the lesion was strangulated and energized, but it did not cut.The procedure was completed with another of the profile snare.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 e1: (b)(6) block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: (product investigation) one profile snare was received for analysis.Visual inspection of the returned device revealed that the distal tip of the working length was bent.Functional evaluation of the returned device found that the device was able to extend completely and retract without issues the reported problem of "loop failed to cut" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this is not a new failure type, and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found bent at the distal tip of the working length during visual test.No issue was noted during functional test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a profile extra small oval flexible snare was used to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on an unknown date.During the procedure and inside the patient, the lesion was strangulated and energized, but it did not cut.The procedure was completed with another of the profile snare.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
• 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: 15670450
• Report Number: 3005099803-2022-06300
• Device Sequence Number: 6372596
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: 12/05/2024
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0028494726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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