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

Model Number	M0054665R0
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that spy ds controller was used on (b)(6) 2024.It was reported that when catheter was connected to unit, the connection light came on but automatically powered off, when catheter was pushed hard into the unit, light came on again but as soon as the push was released light went off.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 (impact codes): impact code f1001 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.Normal wear and tear was observed on top cover, main housing and front panel.The cable connector socket was discolored and contact pins were sticky.There appears to be unknown contamination from fluid ingress on the pins, causing intermittent video.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
It was reported to boston scientific corporation that spy ds controller was used on (b)(6) 2024.It was reported that when catheter was connected to unit, the connection light came on but automatically powered off, when catheter was pushed hard into the unit, light came on again but as soon as the push was released light went off.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: 20568430
• Report Number: 3005099803-2024-05339
• Device Sequence Number: 7460264
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: M0054665R0
• Device Catalogue Number: 4665R
• Device Lot Number: 2330300037
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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