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); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

This report pertains to a spyscope ds ii access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds - digital controller were used in during biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii flickered and became disturbed in the middle of the procedure during electrohydraulic lithotripsy (ehl), and after a while the image on the screen disappeared.The procedure was not completed due to this event.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.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Manufacturer Narrative

This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.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.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there was elevator marks on the shaft of the catheter.An image assessment for visualization was performed.Upon plugging the device into the controller, a grainy image was displayed.Articulation of the catheter had no effect on the image.A short while after insertion of the device into the controller, image would be disrupted.The initialization screen appeared and the image was lost.Reinsertion of the device into the controller did not restore 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 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 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; image could not be restored.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.Pressure readings were recorded using a pressure gage and the device was pressurized until a reading of 6 psi displayed on the gage.Capacitance readings were recorded using an lcr meter while the fluid was being injected.A change in pressure and capacitance was observed and a leak in the handle was observed as well.The external shaft was wrapped with polytetrafluoroethylene (ptfe) tape and another leak test was conducted.Another drop in pressure was observed indicating that the presence of an internal leak.Visual inspection of the pebax showed a no problems with the pebax or the optics lumen.The optics lumen was sealed using a glue cap and a leak test was conducted again.This time a leak was not observed; fluid was not seen exiting the proximal end.Curve trace of the camera wires was performed and identified electrical problems.An open circuit between the data- and data+ camera wires were noted and a short circuit between the ground and power camera wires were noted as well.Visual inspection of the camera wire did not show any damage to the camera wires or the camera wire jacket.The reported event was confirmed.During product analysis, a grainy image was seen upon initial insertion of the device.The image would be disrupted without any interaction with the device; the initialization screen appeared followed by loss of image.Visual inspection of the device along with x-ray assessment did not identify any problems.Therefore, the camera wires of the device were curve traced.The curve trace results showed an open circuit between the data- and data+ camera wires and a short circuit between the ground and power camera wires.Furthermore, a leak test was conducted and confirmed the presence of an internal leak.This indicates that a leak path into the optics lumen was present and may have caused the electrical issues observed in the curve trace.Therefore, it is likely that the problem mode responsible for the reported visualization problem is a pof coupler leak.An investigation to address this problem has been completed.Based on all gathered information, the most probable cause of this complaint is cause traced to device design, which indicates that the problems are traced to the design specifications.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 access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds - digital controller were used in during biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii flickered and became disturbed in the middle of the procedure during electrohydraulic lithotripsy (ehl), and after a while the image on the screen disappeared.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on march 12, 2023: it was reported that the spyglass ds controller is not available for return because the controller is still in service which indicates that the spyglass ds controller has been used and work as intended since 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: 16501533
• MDR Text Key: 311109671
• Report Number: 3005099803-2023-01205
• 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: 04/27/2023

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: 4661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/12/2023
• Supplement Dates FDA Received: 04/28/2023
• 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