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

Model Number	M00546650
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: 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 3005099803-2024-02050 for the spyscope ds ii access & delivery catheter and 3005099803-2024-02049 for the spy ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedures performed for the treatment of biliary stones in the biliary duct on (b)(6) 2024.During the procedure, the spyscope ds ii did not provide an image.The spy ds controller was disconnected and reconnected; turned off and on a few times without success.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/ cancelled procedure.Block h10: 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 was cracked and wear and tear was observed on the top cover.Catheter interface contacts were worn and unknown contamination was present causing video to be lost.The reported clinical observation was 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.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-02050 for the spyscope ds ii access & delivery catheter and 3005099803-2024-02049 for the spy ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedures performed for the treatment of biliary stones in the biliary duct on (b)(6) 2024.During the procedure, the spyscope ds ii did not provide an image.The spy ds controller was disconnected and reconnected; turned off and on a few times without success.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

• 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: 19229295
• Report Number: 3005099803-2024-02049
• Device Sequence Number: 6980770
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 07/15/2024

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2018
• 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