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 10/20/2023

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06083 for the advanix naviflex stent.For the spyscope ds ii access & delivery catheter.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used along with a spybasket and trapezoid basket during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedures performed for the treatment of multiple stones on october 20, 2023.During the procedure, the physician started to access the common bile duct and everything worked well so far.They tried to remove a migrated advanix stent with a spybasket, however, it was unsuccessful.In addition, the patient had multiple stones; therefore, they removed the spyscope dsii to clear the stones first using a trapezoid basket.Cleaning the bile duct lasted for half an hour.They re-inserted the spyscope dsii to remove the stent, however, after half an hour of used the visualization was lost.There was no alleged malfunction of the spybasket and trapeziod basket used on this case.The procedure was cancelled due to this event and was completed on (b)(6) 2023 using another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Block h6 (impact codes): impact code f05 is being used to capture the reportable event of delay to treatment/ therapy.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06083 for the advanix naviflex stent and 3005099803-2023-05849 for the spyscope ds ii access & delivery catheter.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used along with a spybasket and trapezoid basket during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedures performed for the treatment of multiple stones on (b)(6) 2023.During the procedure, the physician started to access the common bile duct and everything worked well so far.They tried to remove a migrated advanix stent with a spybasket, however, it was unsuccessful.In addition, the patient had multiple stones; therefore, they removed the spyscope dsii to clear the stones first using a trapezoid basket.Cleaning the bile duct lasted for half an hour.They re-inserted the spyscope dsii to remove the stent, however, after half an hour of used the visualization was lost.There was no alleged malfunction of the spybasket and trapeziod basket used on this case.The procedure was cancelled due to this event and was completed on (b)(6) 2023 using another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Block h6 (impact codes): impact code f05 is being used to capture the reportable event of delay to treatment/ therapy.Block h10 the returned spyscope ds ii was analyzed, and a visual evaluation was performed.Elevator marks were noted 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 catheter working length using the steering wires at the handle caused image to be disrupted.The initialization screen appeared immediately; image would be restored when the working length of the catheter was in a straight orientation.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.The distal cap was removed to visually inspect the camera wires at the distal end.Visual inspection of the camera wires at the distal tip showed damage in the form of nicked camera wire insulation and a break in camera wire along with potential corrosion.The reported complaint was confirmed.During x-ray assessment of the distal tip, potential camera wire damage was noted in the form of a break and potential corrosion.Initial insertion of the device did yield a live image; however, articulation of the catheter working length caused image to be disrupted.Visual inspection of the camera wire removed from the catheter identified a nick in the insulating wire jacket in the location of the wire break.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 as no live image was displayed and complaint details state a loss of visualization early into the procedure.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.Therefore, based on all gathered information, the most 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: 18085703
• MDR Text Key: 327548448
• Report Number: 3005099803-2023-05849
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2023

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: 0031882273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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