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

Model Number M00546610

Device Problem Optical Problem (3001)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of delay to treatment/therapy.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the common bile duct during a cholangioscopy procedure performed for the treatment of stricture on (b)(6) 2024.During the procedure, the nurse switched on the controller and waited until the start screen appeared.The spyscope was then inserted but only grey spots were visible.The spyscope was disconnected and attempted to reconnect it again to the controller, but there was still no visualization.There was not another spyscope available, so the procedure was rescheduled for a few days later and completed with another spyscope ds ii.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf 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, no image was displayed.Articulation of the catheter had no effect in restoring an image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).No camera wire damage was observed in x-ray imaging of the distal cap.No camera wire damage was observed in the pebax region 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).X-ray assessment of the umbilicus housing shows no problems with the umbilicus connector; the umbilicus connector was confirmed to be in contact with the pins of the umbilicus board.The handle was opened and the electrical components inside were inspected visually.There was no procedural residue seen near the plastic optic fibers pof.Visual assessment showed no problems with 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 umbilicus of the device was replaced with a known working umbilicus and a live image was displayed.The umbilicus connector was inspected, and the board was noted to be misaligned or not in center.The handle was opened to realign the umbilicus board and it was noted that a corner of the board was crushed which indicates that the board was not aligned properly before the handle was closed.The board was realigned, and the umbilicus was inserted into the controller.A live image was produced.The reported complaint was confirmed.The reported clinical observation of no visualization was confirmed.Product analysis found the cause was likely a misaligned umbilicus pcba which may have prevented full contact of the pads with the pins of the controller.The spyscope ds ii access & delivery catheter manufacturing documents detail the process of securing the umbilicus board into a board slot in the umbilicus housing; however, there is no step that verifies board alignment before the housing is closed or assembled.Therefore, the investigation determined that the inspection steps were inadequate at the time this lot was manufactured and the most probable root cause for the visualization problem is quality control deficiency.Manufacturing process changes are currently in progress to minimize the occurrence of the misaligned umbilicus pcba.This includes an additional confirmation step to visually inspect the umbilicus board for alignment/straightness.The manufacturing process documents were updated to include the additional confirmation step in march 2024 and the process changes will be monitored for effectiveness.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the common bile duct during a cholangioscopy procedure performed for the treatment of stricture on (b)(6) 2024.During the procedure, the nurse switched on the controller and waited until the start screen appeared.The spyscope was then inserted but only grey spots were visible.The spyscope was disconnected and attempted to reconnect it again to the controller, but there was still no visualization.There was not another spyscope available, so the procedure was rescheduled for a few days later and completed with another spyscope ds ii.There were no patient complications reported as a result of this event.

• 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: 18659741
• MDR Text Key: 334806565
• Report Number: 3005099803-2024-00383
• 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: 04/23/2024

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: 0031813815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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