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 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the image from the spyscope ds ii was lost approximately two minutes into the procedure while flushing the bile duct.The procedure was not completed due to this event.There were no patient complications reported as 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 retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the image from the spyscope ds ii was lost approximately two minutes into the procedure while flushing the bile duct.The procedure was not completed due to this event.There were no patient complications reported as result of this event.

Manufacturer Narrative

Block e1 (initial reporter facility name) (b)(6) hospital.Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.The returned spyscope ds ii was analyzed, and a visual evaluation noted that there were no elevator marks 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 for visualization was performed.The device was plugged into the controller.A live, clear image was displayed.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected, and no damage or defects were noted.The device was fully articulated in all directions; no problems were identified with the image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl) or thru-silicon vias (tsvs).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 components within were visually inspected.It was noted that there was procedural residue on the plastic optical fibers (pofs) and on the pcba board in the breakout region, indicated procedural fluids had flowed back up the optics lumen into the handle during use.The tip was blocked, and saline was flushed through the irrigation tubing to induce backflow of saline into the optics lumen.This caused loss of image.The saline was drained from the optics lumen and the image was restored.The reported complaint was confirmed.During product analysis, when saline was introduced in the optics lumen, image was lost.The image signal does not withstand the change in capacitance created by the introduction of saline into the optics lumen, and procedural factors can cause this fluid to enter the optics lumen during use.Based on all gathered information, the probable cause selected for the image failure due to fluid in the optics lumen 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.

• 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: 15921056
• MDR Text Key: 308091843
• Report Number: 3005099803-2022-07166
• 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: 01/18/2023

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: 0029922480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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