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 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

(impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during an endoscopic cholangiography procedure performed on (b)(6) 2022.During the insertion, the image from the spyscope ds ii disappeared within 1 minute of usage.Reportedly, the image can be displayed outside the body, but the image cannot be seen inside the bile duct.The device was set at the same angle and it was passed through the duodenoscope, the image was displayed.They have it three times, however, the image didn't show up when it was in the bile duct.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during an endoscopic cholangiography procedure performed on (b)(6) 2022.During the insertion, the image from the spyscope ds ii disappeared within 1 minute of usage.Reportedly, the image can be displayed outside the body, but the image cannot be seen inside the bile duct.The device was set at the same angle and it was passed through the duodenoscope, the image was displayed.They have it three times, however, the image didn't show up when it was in the bile duct.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): 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 signs of use in the form of elevator marks were noted on the shaft of the catheter.Elevator marks were measured from the tip.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 for visualization was performed.The device was plugged into the controller.A live, clear image was displayed.No problems were identified with the image.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected, and no damage or defects were noted.The lighting controls on the controller were tested and the scope lighting adjusted accordingly, no problems were observed with scope lighting or plastic optical fibers (pofs).The device was fully articulated in all directions; no problems were identified with the image; no issues were identified with the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl), thru-silicon vias (tsvs), or camera wire.X-ray imaging of the handle showed no problems 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.Signs of procedural residue were present inside the handle.The tip was blocked and saline was flushed through the irrigation tubing to induce backflow of saline into the optics lumen.No change to the image was noted during this saline test.The reported event was not confirmed.Product analysis was unable to replicate the reported problems.The device functioned properly throughout analysis and appeared used.Based on all gathered information, the complaint investigation conclusion code selected for the visualization issue is no problem detected, which indicates that the device complaint or problem cannot be confirmed.

• 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: 16035771
• MDR Text Key: 308396009
• Report Number: 3005099803-2022-07668
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: 1759-02
• Device Lot Number: 0029931642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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