MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL SNARE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	M00546560
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of snare loop detached.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval snare was used during a metallic stent removal procedure performed on (b)(6) 2023.During the procedure, a spysnare loop wire broke inside the patient while trying to retrieve a metallic stent.The loop wire was retrieved with forceps and a plastic stent was implanted since the metallic stent could not be removed.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS RETRIEVAL SNARE
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16693645
• Report Number: 3005099803-2023-01688
• Device Sequence Number: 7362924
• Product Code: PTS
• UDI-Device Identifier: 08714729965893
• UDI-Public: 08714729965893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00546560
• Device Catalogue Number: 4656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown