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); 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 on the shaft of the catheter.No damage was noted.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.An image assessment was performed.The device was plugged into the controller.No image was displayed.The device was fully articulated in all directions; the device continued to not display a live image.X-ray imaging of the distal tip showed no problem with the redistribution layer (rdl), thru-silicon vias (tsvs), or camera wire.X-ray imaging of the handle showed no problem with the printed circuit board assembly (pcba) or camera wires.The handle was opened and the connection of the camera wires to the pcba was inspected.No damage or defect was noted on the bond between the solder pads and the camera wires.The glue feature was wiggled with tweezers to test the solder bond of the wires, and no change to the image was noted.Pressure was applied to the ground pad on the pcba using a screwdriver, and no flex was observed on the pcba.It appeared fully bonded to the breakout and no components on the board appeared damaged.The camera wire in the breakout region was visually inspected.No damage was noted to the camera wire or jacket.The umbilicus assembly was replaced with a known good assembly and the image was tested again by connecting the device to a controller, and the device continued to not display a live image.The reported event was confirmed.A review of the risk documentation confirms that the problem is not a new or unanticipated event, and therefore it is unlikely an issue with the design of the device.Although product analysis was unable to replicate the reported event, testing was unable to determine the cause of the failure.Based on all gathered information, the complaint investigation conclusion code selected is cause not established, which indicates that the investigation did not lead to a clear conclusion on the cause of the reported event.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

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: 11047946
• MDR Text Key: 222763698
• Report Number: 3005099803-2020-06329
• 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: 02/10/2021

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: 09/04/2022
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 25969541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1