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

Model Number	M00561821
Medical Device Problem Codes	Retraction Problem (1536); Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.
Event or Problem Description
It was reported to boston scientific that a rotatable snare was used during a procedure on (b)(6) 2025.During the procedure, the loop retraction failed, and the loop was only partially retracted.The facility normally uses a rotatable snare, but during polypectomy with energization, the sharpness was poor, and the removal could not be completed.Upon checking the device, it was found that the loop could not be completely retracted.The procedure was completed using another rotatable snare.There were no further patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.Block h11: investigation results- visual analysis of the returned device revealed no visible damage.The reported event of "loop retraction problem" and "loop failure to cut" could not be confirmed, as the device extended and retracted properly during functional testing, and electrical continuity tests were within specification.The risk review confirmed that the event of "loop failure to cut" is defined in the risk documentation and appropriately documented in the product risk review (prr), with the event type accounted for during product risk analysis to support the product's acceptable risk-benefit profile.Based on all available information, the overall conclusion is "no problem detected," as the device functioned as intended and no defect or abnormality was identified that could have contributed to the reported event.No further escalation is required.
Event or Problem Description
It was reported to boston scientific that a rotatable snare was used during a procedure on (b)(6) 2025.During the procedure, the loop retraction failed, and the loop was only partially retracted.The facility normally uses a rotatable snare, but during polypectomy with energization, the sharpness was poor, and the removal could not be completed.Upon checking the device, it was found that the loop could not be completely retracted.The procedure was completed using another rotatable snare.There were no further 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21927289
• Report Number: 3005099803-2025-01818
• Device Sequence Number: 8796153
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: M00561821
• Device Catalogue Number: 6182
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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