MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS? DISCOVER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546780
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
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 two spy discover catheters used during the same patient and the same procedure.It was reported to boston scientific corporation that two spy discover catheters were attempted for use in the cystic duct with common bile duct during a laparoscopic cholecystectomy procedure on (b)(6) 2025, for the treatment of choledocholithiasis.During the procedure, the visualization flickered and then changed to the loading screen approximately ten minutes after the fluidics pump was introduced for irrigation.Attempts to restore visualization by unplugging and reconnecting the device were unsuccessful.They attempted to use a second spy discover catheter, which presented with the same malfunction.A balloon sweep was then attempted but failed to remove the stone.After a delay of approximately 30 minutes, the laparoscopic cholecystectomy procedure was discontinued.The patient was then sent interventional radiology (ir) for a percutaneous transhepatic cholangiography (ptc).No patient complications were 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 h 11: the device was returned for evaluation.During the media inspection, the attached photo showed that when the device was connected to the controller, no image was displayed.Visual inspection confirmed that the device was returned with no visible damage.During the image test, the device was again connected to the controller and did not display an image.Functional inspection showed that the camera tip articulated without any issues; however, this did not resolve the image problem.No residue was observed in the breakout region of the handle.Electrical testing indicated that the measurements were not within the expected values.Microscopic and destructive testing revealed damage to the camera cables.During the leak test, the device showed no leaks, and the capacitance and psi levels remained stable throughout the test, with the image remaining on.Additional microscopic and destructive evaluation showed that the camera wires were intact, but the pebax material was damaged.Product analysis confirmed the reported events of spyscope loss of visualization and poor image quality.The visualization issues most likely resulted from a failure of the camera assembly during the procedure, as supported by the electrical test findings.After disassembly and microscopic inspection of the handle pcba components, the distal section of the insertion tube was cut and examined, revealing a tear in the pebax material.Pebax, a flexible material located at the distal tip, can be damaged by handling or external forces during preparation or use.Additionally, "spyscope camera curve trace failure" will be added to address the image and electrical failures, and "spyscope damaged" will be added to address the pebax damage.Therefore, a review and analysis of all available information indicate the most probable cause is cause traced to component failure.The impact code cancelled/rescheduled - post sedation/sedation unknown and prolonged episode of care will be addressed as adverse event related to procedure due to the difficulties faced during the procedure with the scope.A risk review performed for the spyscope ds ii device confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the spyscope ds ii device is acceptable.
Event or Problem Description
Note: this report pertains to one of two spy discover catheters used during the same procedure.It was reported to boston scientific corporation that two spy discover catheters were attempted for use in the cystic duct with common bile duct during a laparoscopic cholecystectomy procedure on (b)(6) 2025, for the treatment of choledocholithiasis.During the procedure, the visualization flickered and then changed to the loading screen approximately ten minutes after the fluidics pump was introduced for irrigation.Attempts to restore visualization by unplugging and reconnecting the device were unsuccessful.They attempted to use a second spy discover catheter, which presented with the same malfunction.A balloon sweep was then attempted but failed to remove the stone.After a delay of approximately 30 minutes, the laparoscopic cholecystectomy procedure was discontinued.The patient was then sent interventional radiology (ir) for a percutaneous transhepatic cholangiography (ptc).No patient complications were reported as a result of this event.

• Brand Name: SPYGLASS? DISCOVER
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24184304
• Report Number: 3005099803-2026-00302
• Device Sequence Number: 13266063
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)270815(10)40363331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200483
• 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,Followup
• Report Date (Section B): 03/26/2026

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: M00546780
• Device Catalogue Number: M00546780
• Device Lot Number: 0040363331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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