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

Model Number M00546610

Device Problems Device-Device Incompatibility (2919); Optical Problem (3001)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.During the procedure, the image from the spyscope ds ii was lost and got black screen with 3 gray dots after two pulses of using electrohydraulic lithotripsy (ehl).They tried to unplug, replugged, blow on controller, wipe connectors with alcohol wipes; however, the problem was not resolved.The procedure was not completed due to this event.A stent was placed inside the patient and will be brought back on a later date to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2022.During the procedure, the image from the spyscope ds ii was lost and got black screen with 3 gray dots after two pulses of using electrohydraulic lithotripsy (ehl).They then tried to unplug, replugged, blow on controller, wipe connectors with alcohol wipes; however, the problem was not resolved.The procedure was not completed due to this event.A stent was placed inside the patient and will be brought back on a later date to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.The returned spyscope ds ii was analyzed, and a visual evaluation noted that there 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 displayed.Articulation of the catheter had no effect on the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).No 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 inside were inspected visually.There was 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.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.Capacitance readings were recorded using an lcr meter while the fluid was being injected and a change in capacitance was observed.This indicates that the backflow of saline into the optics lumen was causing a disruption of capacitance and that a leak path was present.The external shaft was wrapped in ptfe tape to test if there was external leakage, and the leak test was performed again.Another change in capacitance was observed and image was disrupted.Solid purple lines appeared on the screen followed by the initialization screen and loss of image.This indicated that the leak was internal.A portion of the working length was cut to visually inspect the pebax inside the distal cap.Visual assessment of the pebax showed no problems; there was no damage seen.The reported event was confirmed.During product analysis, a live image was seen upon insertion of the device and after a leak test, the image was disrupted.Solid purple lines appeared followed by the initialization screen and loss of image.A leak test confirmed that there was a leak path into the optics lumen, but the exact location of the leak could not be determined during analysis.The pebax is a flexible material at the tip where damage may occur through handling or external forces during procedure and allows for a leak to occur.Based on all gathered information, the probable cause selected for this complaint is cause traced to component failure, which indicates that the problem is a random or expected component failure, in this case the pebax, with no element of design or manufacturing.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: 16075547
• MDR Text Key: 307025637
• Report Number: 3005099803-2022-07840
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: 4461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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