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 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): 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 three devices used during the same procedure.Refer to manufacturer report number for the first spyscope ds ii, report number 3005099803-2023-06373 for the second spyscope ds ii and report number 3005099803-2023-06371 for the spy ds controller.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and per-oral cholangioscopy (poc) procedures performed for the diagnosis of stricture in the bile duct on (b)(6) 2023.During the procedure, the first spyscope ds ii malfunctioned after a couple of minutes of usage and then five grey dots appeared across the screen.A second spyscope ds ii was then used; however, no image appeared and went back to the initial start-up screen asking them to connect the device.The spyscope ds ii was unplugged and re-plugged from the spy ds controller, but the image was not displayed.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06372 for the first spyscope ds ii, report number 3005099803-2023-06373 for the second spyscope ds ii and report number 3005099803-2023-06371 for the spy ds controller.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and per-oral cholangioscopy (poc) procedures performed for the diagnosis of stricture in the bile duct on (b)(6) 2023.During the procedure, the first spyscope ds ii malfunctioned after a couple of minutes of usage and then five grey dots appeared across the screen.A second spyscope ds ii was then used; however, no image appeared and went back to the initial start-up screen asking them to connect the device.The spyscope ds ii was unplugged and re-plugged from the spy ds controller, but the image was not displayed.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6 (impact codes): 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, and a visual evaluation noted that there were 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.No camera wire damage was observed in the pebax region of the catheter proximal to the working channel sleeve.X-ray imaging of the handle showed no problems 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 showed no problems with the camera wires in the glue feature.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 based on the reported loss of visualization and residue was noted near the breakout.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 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 external shaft of the distal end was wrapped in polytetrafluoroethylene (ptfe) tape, and a leak test was conducted again, and pressure dropped again.The presence of an internal leak was confirmed.Visual inspection of the pebax showed no problems.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 no longer observed.The reported complaint 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; fluid was also seen leaving the breakout.The pebax was visually inspected, and no damage was noted.Sealing the optics lumen with glue caused the leak to stop.Based on analysis findings, the most probable location of the leak is the pof coupler.The pebax is a flexible material at the tip where damage may occur through handling or external forces during procedure and allows for a leak to occur.Based on all gathered information, the probable cause selected for the visualization issue 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: 18301762
• MDR Text Key: 330353879
• Report Number: 3005099803-2023-06372
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/13/2024

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: 0032407287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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