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

Model Number M0054665Z0

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-01208 for the spyscope ds ii access & delivery catheter and 3005099803-2024-01207 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 in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass dsii procedure performed for the treatment of pancreatic lithiasis on (b)(6), 2024.During the procedure, the image became blue when the video cable of the spy ds controller was moved.They switched to a different video cable however, it did not work.They continued the procedure since the image was visible.Approximately one hour later, the image of the spyscope ds ii was lost.The ercp was unable to be completed as a result of this event.An advanix biliary stent was placed, and a follow-up procedure was planned for a continuous treatment of the patient.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DS DIGITAL CONTROLLER
• Type of Device: 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: 18960199
• MDR Text Key: 338435391
• Report Number: 3005099803-2024-01207
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0054665Z0
• Device Catalogue Number: 4665Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female