MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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 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.

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.

Manufacturer Narrative

Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed.Visual evaluation noted elevator marks on the shaft of the catheter.An image assessment for visualization was performed.Upon plugging the device into the controller, a live image was displayed.Articulation of the working length using the steering wheels at the handle had no effect on image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).No damage to the camera wires was observed in x-ray assessment of the distal end and no camera wire damage was observed in the pebax region of the catheter proximal to the working channel sleeve.Imaging of the handle showed no damage to the camera wires with the breakout region or camera wires around the strain relief.X-ray imaging shows no damage to the camera wires at the printed circuit board assembly (pcba).The handle was opened and the electrical components inside were inspected visually.There was procedural residue seen in the plastic optic fibers (pof).Visual assessment of the glue feature showed no problems.The bond of the glue feature to the pcba was inspected; tweezers were used to wiggle the glue feature.The connection of the camera wires to the pcba was also inspected by slightly lifting the bottom of the glue feature for each of the four camera wires using the tip of the tweezers.No impact to the image was seen after these interactions.A leak test was conducted to determine if a leak path into the optics lumen was present.The device was pressurized by injecting fluid through the irrigation port of the device while the distal end was inserted into a mock common bile duct (cbd) fixture.Pressure readings were recorded using a pressure gage and the device was pressurized until a reading displayed on the gage.Capacitance readings were recorded using a liquidity coverage ratio (lcr) meter while the fluid was being injected.A drop in pressure and an increase in capacitance was observed.Fluid was also seen leaving the breakout and image was disrupted.Pink lines appeared on the screen followed by the initialization screen and loss of image.The reported event was confirmed.The external shaft of the distal end was wrapped in polytetrafluoroethylene (ptfe) tape, another leak test was conducted, and pressure dropped again.The presence of an internal leak was confirmed.Visual inspection of the pebax showed no obvious damage.A borescope was used to observe the inside of the optics lumen for any damage.Visual inspection of inside the optics lumen noted no problems.The optics lumen was sealed using a glue cap and a leak test was conducted again.A leak was still observed; fluid was observed exiting the proximal end of the tip.The reported event was confirmed.During product analysis, a leak test confirmed the presence of a leak in the form of a drop in pressure and an increase in capacitance.Introduction of fluid into the optics lumen affects the electrical properties and can disrupt the image.The pebax, a flexible material at the tip of the catheter, can be damaged through handling or external forces during procedure and allow for a leak to occur.Based on all gathered information, the probable cause selected for the visualization problem is cause traced to component failure, which indicates that the failure is a random or expected failure of the device component, in this case the internal coupler.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18960198
• MDR Text Key: 338372196
• Report Number: 3005099803-2024-01208
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K183636
• 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,Followup
• Report Date: 05/07/2024

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
• Device Operator: Health Professional
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0032538854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female