MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number	M00560321
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw snare was to be used during an unknown procedure performed on (b)(6), 2025.During preparation and outside the patient, the hospital inspected the goods and discovered foreign bodies inside the sterile packaging.Although the objects were not clearly visible, they were suspected to be metal wires.The procedure was not performed due to another reason.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw snare was to be used during an unknown procedure performed on (b)(6) 2025.During preparation and outside the patient, the hospital inspected the goods and discovered foreign bodies inside the sterile packaging.Although the objects were not clearly visible, they were suspected to be metal wires.The procedure was not performed due to another reason.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Block h11: the returned sensation short throw was analyzed, and a visual and microscope inspection found a foreign material inside of the pouch.A photo is attached where the foreign material can be observed.No other issues with the device were observed in the photo.The reported event of device foreign material present in device was confirmed.Investigation found that a foreign material inside of the pouch.An investigation to address this issue is in progress.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.

• Brand Name: SENSATION SHORT THROW
• 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: 22935151
• Report Number: 3005099803-2025-04389
• Device Sequence Number: 13231222
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: (01)08714729283928(17)271121(10)35340405
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: M00560321
• Device Catalogue Number: 6032
• Device Lot Number: 0035340405
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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