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 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2023 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Notes: this report pertains to two spyscope ds ii complaints used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii complaints were used in the bile duct during a stone removal procedure performed for the treatment of common bile duct stone on an unknown procedure date.During the procedure, the image from the spyscope ds ii was not displayed from the start.It was reported that no image appeared on the screen when the spyscope ds ii was connected to the controller.A second spyscope ds ii was used; however, the same problem occurred.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The provided event date 01oct2023 was chosen as a best estimate based on the date that the manufacturer became aware of the event.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 one elevator mark 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 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).The handle was opened and the electrical components inside were inspected visually.There was 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.A leak test was conducted to determine if a leak path into the optics lumen was present based on presence of residue observed at the breakout.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.No change in pressure was observed after injection of fluid.The live image was stable as well and no changes were observed.The reported complaint was not confirmed.During product analysis, a live image was seen upon insertion of the device and after conducting a leak test, no leak was observed; there were no changes to the live image.Based on all gathered information, the probable cause selected is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use ifu / product label.

Event Description

Notes: this report pertains to two spyscope ds ii complaints used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii complaints were used in the bile duct during a stone removal procedure performed for the treatment of common bile duct stone on an unknown procedure date.During the procedure, the image from the spyscope ds ii was not displayed from the start.It was reported that no image appeared on the screen when the spyscope ds ii was connected to the controller.A second spyscope ds ii was used; however, the same problem occurred.The procedure was not completed due to this event.There were no reported patient complications 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: 18119411
• MDR Text Key: 327927330
• Report Number: 3005099803-2023-06043
• 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: 12/28/2023

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: 0031436608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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