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

Model Number	M00546650
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04619 for the first spyscope ds ii access & delivery catheter, 3005099803-2024-04620 for the second spyscope ds ii access & delivery catheter, and 3005099803-2024-04785 for the spy ds controller.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheters were used with a spy ds controller in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed for the treatment of common bile duct stones on (b)(6) 2024.During the procedure, when the physician attempted to use the spyglass, the catheter did not show any lights when plugged into the controller.Reportedly, they opened a second spyglass.However, the second catheter did not work either.The physician placed a plastic stent, and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04619 for the first spyscope ds ii access & delivery catheter, 3005099803-2024-04620 for the second spyscope ds ii access & delivery catheter, and 3005099803-2024-04785 for the spy ds controller.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheters were used with a spy ds controller in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed for the treatment of common bile duct stones on (b)(6) 2024.During the procedure, when the physician attempted to use the spyglass, the catheter did not show any lights when plugged into the controller.Reportedly, they opened a second spyglass.However, the second catheter did not work either.The physician placed a plastic stent, and 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 absence of treatment.Block h11: investigation results.The returned spy ds controller was analyzed.It was found that the catheter interface contacts have contamination and unknown debris adhered causing a lack of video.No other problems were noted.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.It is likely due to repeat use and wear and tear on the catheter connection, or improper cleaning of the unit during maintenance.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: 20304204
• Report Number: 3005099803-2024-04785
• Device Sequence Number: 18078764
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 1803900033
• 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: 08/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown