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)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter phone: (b)(6).Block h6: imdrf 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 access & delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, there was a sort of interference and partial loss of visualization of the image on the screen.Some minutes later, the screen did not show any image.They unplugged and replugged the spyscope a couple of times but the problem persisted.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: initial reporter phone: (b)(6).Block h6: 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 that there were elevator marks 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 problem with the redistribution layer (rdl).No camera wire damage was observed near the distal end.No camera wire damage was observed in the pebax region of the catheter.X-ray imaging of the handle showed no problem 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 in the plastic optic fibers (pof), visual assessment showed no problem with the camera wires in 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 saline test was conducted, based on residue at the pofs, and after insertion of saline, enough to reach the handle, the image was disrupted.Purple and pink lines appeared on the screen followed by the initialization screen.The reported complaint regarding visualization was confirmed.During product analysis, a live image was seen after insertion of device into controller.After a saline test, image was disrupted.Purple and pink lines appeared followed by the initialization screen.During procedure, fluid likely back flowed into the optics lumen and caused a change in capacitance of the electrical circuit resulting in a loss of image.An investigation to address this problem has been completed.Based on all gathered information, the probable cause selected for the image failure 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.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, there was a sort of interference and partial loss of visualization of the image on the screen.Some minutes later, the screen did not show any image.They unplugged and replugged the spyscope a couple of times but the problem persisted.The procedure was not completed due to this event.There were no patient complications reported 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: 17309598
• MDR Text Key: 319670323
• Report Number: 3005099803-2023-03565
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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: 08/22/2023

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 Expiration Date: 03/15/2024
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0029052767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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