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 08/29/2023

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 a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass digital controller were used in the hepatobiliary pancreas on (b)(6) 2023.The type of procedure is unknown.During the procedure, the image was disappeared approximately five minutes into the procedure.The procedure was not completed due to this event.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 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 was performed.One 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 using the steering wheels at the handle had no effect in restoring an image.X-ray imaging of the distal tip showed no problem with the redistribution layer (rdl).No camera wire damage was observed in x-ray imaging 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 problem 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 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 effect in restoring an image was seen after these interactions.The reported complaint regarding visualization was confirmed.The analysis of the returned device revealed that no image was seen upon initial insertion.Visual inspection of the exterior of the device along with x-ray assessment of the camera wire did not identify any problem.Therefore, the camera wires of the device were curve traced.The curve trace results showed a short circuit between the data and ground camera wire connections and a highly resistive/open circuit between the data and power camera wire connections.The camera wire was then removed from the working length and visually inspected.Visual assessment showed no signs of camera wire damage.As there were no manufacturing deviations noted, the visualization problem is most likely due to a random problem of the camera assembly during procedure, as evident by the curve trace results.Based on all gathered information, the probable cause selected for the image failure is cause traced to component failure, which indicates that a random failure with a device component contributed to the event.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass digital controller were used in the hepatobiliary pancreas on (b)(6) 2023.The type of procedure is unknown.During the procedure, the image was disappeared approximately five minutes into the procedure.The procedure was not completed due to this event.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 stable.

• 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: 17774249
• MDR Text Key: 323737702
• Report Number: 3005099803-2023-04960
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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: 0032016367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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