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

Model Number	M00561821
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: h4 the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used during an unknown procedure performed on (b)(6) 2025.During the procedure, outside the patient, there was a connection problem of the active code connector as it has loosened and disconnected.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4: h4.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Block h10: investigation results: a rotatable snare was received for analysis.Visual inspection visual inspection that the cautery was detached, and it did not return for analysis.The reported cautery pin detachment of device or device component was confirmed.During product analysis performed on the device, it was found that the cautery was detached, however, the cautery pin did not return for the analysis.The definitive cause of the reported issue cannot be established due to lack of evidence.Additionally, without the cautery pin, the cause of the event is unknown.Therefore, the reported cautery pin detached was classified as cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used during an unknown procedure performed on (b)(6) 2025.During the procedure, outside the patient, there was a connection problem of the active code connector as it has loosened and disconnected.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23182036
• Report Number: 3005099803-2025-04928
• Device Sequence Number: 13222312
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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
• Device Lot Number: 0036714080
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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