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

Model Number	M00546560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval snare was used for proximal migrated stent removal in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) - cholangioscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop was broken.The procedure was completed with another spysnare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code a0401 captures the reportable event of snare loop break.Investigation results: a spyglass retrieval snare was received for analysis.Visual inspection of the returned device revealed that the loop was detached, and the working length was kinked at the distal section.Functional testing was not performed due to the condition of the device.No other problems were noted.Upon product analysis, the event happened during the procedure and the bent observed on the working length may be related to user manipulation and/or some technique applied during the procedure that could result to kinking of the working length.The user may have experienced difficulties while retracting the loop due to the kink present on the device, which led the user to apply additional force/tension, as a consequence the loop was detached.Therefore, the reported complaint of "loop detached/separated" was confirmed.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval snare was used for proximal migrated stent removal in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) - cholangioscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop was broken.The procedure was completed with another spysnare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• 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 CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15631318
• Report Number: 3005099803-2022-06019
• Device Sequence Number: 12230662
• Product Code: PTS
• UDI-Device Identifier: 08714729965893
• UDI-Public: 08714729965893
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 01/25/2023

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 Expiration Date: 03/04/2023
• Device Model Number: M00546560
• Device Catalogue Number: 4656
• Device Lot Number: 0026913301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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 Age: 24 YR
• Patient Sex: Male