MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE

Model Number	M00546650
Medical Device Problem Codes	Device-Device Incompatibility (2919); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-02574 for the spyscope ds ii access & delivery catheter, and 3005099803-2024-02697 for the spy ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used with a spy ds controller in the left hepatic duct to middle bile duct during a biliary lithotripsy procedures performed for the treatment of bile duct stones on (b)(6) 2024.During the procedure, the spyscope ds ii was inserted through the hgs route and ehl was performed at the target site, however, the display on the screen suddenly disappeared, making it difficult to continue the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-02574 for the spyscope ds ii access & delivery catheter, and 3005099803-2024-02697 for the spy ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used with a spy ds controller in the left hepatic duct to middle bile duct during a biliary lithotripsy procedures performed for the treatment of bile duct stones on (b)(6) 2024.During the procedure, the spyscope ds ii was inserted through the hgs route and ehl was performed at the target site, however, the display on the screen suddenly disappeared, making it difficult to continue the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code is being used to capture the reportable event of aborted/cancelled procedure.Block h11 (investigation results): with all the available information, boston scientific concludes that the reported event was confirmed.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.The returned spy ds controller was analyzed.The front panel of the controller has normal wear and tear to the front and top.Identifying labels applied to top.Unknown contamination identified on the catheter contacts causing the contacts to stick and causing an intermittent connection.The allegation has been confirmed.Based on all gathered information, the conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: SPYGLASS DS
• Common Device Name: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19486432
• Report Number: 3005099803-2024-02697
• Device Sequence Number: 18123874
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142922
• 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): 08/20/2024

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: M00546650
• Device Catalogue Number: 4665
• Device Lot Number: 2007700509
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown