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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Imdrf impact code (b)(4) is being used to capture the reportable issue of cancelled/aborted procedure.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.During procedure, while negotiating the spyscope ds ii inside the common bile duct, the device was unable to visualize the image of the internal part because the video was flickering without any image after approximately seven minutes.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: imdrf impact code f1001 is being used to capture the reportable event of cancelled/aborted procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation was performed.Elevator marks at were noted on the shaft of the catheter.Elevator marks measured approximately 32 and 42mm.An image assessment for visualization was performed.The device was plugged into the controller, no image was displayed.Articulation of the catheter had no effect on the image.Distal camera wire damage observed in x-ray assessment was confirmed.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).Potential camera wire damage was observed near the distal end.No camera wire damage was observed in the pebax region of the catheter.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 within 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 reported complaint was confirmed.During product analysis, potential camera wire damage near the distal tip was observed in the form of a knot in wire and a potential break.Upon initial insertion of the device, there was no image, which confirms the distal camera wire damage observed in x-rays.The condition of the wires suggests a lack of controls regarding camera wire handling during the manufacturing process (likely during camera/pof potting, stuffing, and/or pof bonding), resulting in nicked insulation of the camera wires and/or twisting of wires.It is likely that the damage to the camera wire, as well as handling of the device during procedure, created a break in connection of the camera which then caused the reported visualization problem.Based on all gathered information, the probable cause for the visualization problem is due to distal camera wire damage is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.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 during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.During procedure, while negotiating the spyscope ds ii inside the common bile duct, the device was unable to visualize the image of the internal part because the video was flickering without any image.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: 16052947
• MDR Text Key: 307315765
• Report Number: 3005099803-2022-07782
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/27/2023

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: 1759-02
• Device Lot Number: 0029754080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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