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

Model Number M00546610

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to two spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a removal of bile duct stone procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, the nurse plugged in the first spyscope ds ii; however, there was no image detected.Only 5 loading dots appeared on the screen.A second spyscope ds ii was used, and it was noted that the image was intermittent.The spyscope ds ii was reconnected; however, the image was lost approximately 5 minutes into the procedure.The procedure was not completed due to this event.Reportedly, a plastic stent was placed and the patient will be rescheduled in approximately one month.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 (device codes): medical device problem code a27 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 no elevator marks were noted along the shaft of the device.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.The device was connected to a console and no live image was displayed.X-ray imaging of the handle showed no damage to printed circuit board assembly (pcba); however, the camera wires near the breakout region appeared suspicious.The handle was opened and the components within were visually inspected.The camera wires appeared compressed where the steering wires interact in the region of the breakout.The reported event was confirmed.The breakout region of the handle is the routing location for the camera wire, plastic optical fibers (pofs), and steering wires as those components exit the handle.Articulation of the device during procedure causes movement of all of these components in the region.It is possible in this dynamic setting that the camera wire can interact with the steering wires, pofs, or the edges of the breakout.The forces exerted on the camera wires during this interaction have been found to damage the jacket or the conductors within.If the jacket is compromised, the wires are no longer insulated and can come into contact with the steering wires, resulting in an electrical short that will cause the image to turn off if the camera wires are damaged, this results in an electrical open that will cause the image to turn off.An investigation is in place to address this problem.Based on all available information, the probable cause selected for the visualization problem due to camera wire or jacket damage in the breakout region in the handle is cause traced to component failure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaint exist for the specified lot.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 two spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a removal of bile duct stone procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, the nurse plugged in the first spyscope ds ii; however, there was no image detected.Only 5 loading dots appeared on the screen.A second spyscope ds ii was used, and it was noted that the image was intermittent.The spyscope ds ii was reconnected; however, the image was lost approximately 5 minutes into the procedure.The procedure was not completed due to this event.Reportedly, a plastic stent was placed and the patient will be rescheduled in approximately one month.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
• MDR Report Key: 11072367
• MDR Text Key: 223618415
• Report Number: 3005099803-2020-06328
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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 Expiration Date: 10/04/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0026125625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1