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

Model Number	M00561831
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated to november 01, 2024 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block e1: initial reporter city: (b)(6).Block h6: imdrf device a090402 captures the reportable event of device unable to delivery energy.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare device was used in the colon for colon polyps during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During the procedure, the device could not be energized and the polyp could not be removed.The procedure was completed with another rotatable snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
B3: approximated to november 01, 2024, based on the date the manufacturer became aware of the event.D4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.E1: initial reporter city: (b)(6).H6: imdrf device a090402 captures the reportable event of device unable to delivery energy.H11: investigation results: a rotatable snare was received for analysis, and it was found during visual inspection without any visible damages.A continuity and electrical test were performed, and the device was found within specification.No problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed.During analysis of the device, it was determined that the device did not have any visual issues or damages, the device was submitted to a continuity and electrical test, and it was found within specification, the unit returned did not show evidence of the alleged issue or any defect that could have contributed to the event reported.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since product analysis of the returned device and product record review did not identify any evidence of either the alleged problem(s) or any defect on the device.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare device was used in the colon for colon polyps during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During the procedure, the device could not be energized and the polyp could not be removed.The procedure was completed with another rotatable snare device.There were no patient complications reported as a result of this event.

• Brand Name: ROTATABLE SNARE
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20957185
• Report Number: 3005099803-2024-06446
• Device Sequence Number: 12674242
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160637
• 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): 02/13/2025

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 Model Number: M00561831
• Device Catalogue Number: 6183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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