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

Model Number M00546610

Device Problems Poor Quality Image (1408); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the pancreatic duct during a spyglass procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii was lost after one and one-half hour of usage while performing lithotripsy.The screen showed a slow visual image with a lot of lines in different colors and then the image was lost.The procedure was not completed due to another spyscope ds ii was unavailable.It was reported that the physician plans to complete the procedure on (b)(6) 2023.Using another spyscope ds ii.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1 initial reporter address 1: (b)(6).Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the pancreatic duct during a spyglass procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii was lost after one and one-half hour of usage while performing lithotripsy.The screen showed a slow visual image with a lot of lines in different colors and then the image was lost.The procedure was not completed due to another spyscope ds ii was unavailable.It was reported that the physician plans to complete the procedure on (b)(6) 2023 using another spyscope ds ii.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1 initial reporter address 1: (b)(6) 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 not displayed.Articulation of the catheter working length using the steering wires at the handle had no effect in restoring an image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).X-ray imaging inside the distal cap showed no camera wire damage.X-ray assessment of the pebax region proximal to the distal cap shows damage to the camera wires in the form of a break and potential corrosion.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 no 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 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.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 was displayed on the gage.A drop in pressure was not seen after fluid was injected; a leak was not detected.The distal cap of the catheter was pulled on to reveal the camera wires at the distal end.Visual inspection of the camera wires confirmed the presence of damage in the form of nicked camera wire insulation, break in camera wire conductor and potential corrosion of camera wires.The reported complaint was confirmed.During product analysis, the x-ray assessment of the distal tip noted potential camera wire damage in the form of a fold and potential corrosion.Initial insertion of the device into the controller did not yield a live image.Visual inspection of the camera wire removed from the catheter identified a nick in the insulating wire jacket and damage to the wire conductors.Product analysis results indicate that the most probable problem mode for this device was camera wire damage causing an open circuit in the camera signal.Process controls for the problem mode on the manufacturing line include visual inspection and tooling designed to decrease the chances of wire damage during production.Camera calibration data was able to be obtained during returned product analysis indicating that the camera was properly calibrated and checked for an image, suggesting that the camera wire was intact throughout manufacturing.However, the camera wire is enclosed within the catheter once manufacturing is complete.Therefore, it is likely that assembly process steps such as camera/ pof potting, stuffing, and/ or pof bonding, and subsequent handling of the device, left the camera wire in a vulnerable state, leading to the wire fracture and image problems during field use.Based on all gathered information, the probable cause selected for the visualization problem is quality control deficiency.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: 17831275
• MDR Text Key: 324992830
• Report Number: 3005099803-2023-05023
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 12/19/2023

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: 0032112080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2023
• 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 Age: 34 YR
• Patient Sex: Male