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 11/20/2023

Event Type  malfunction  

Event Description

Notes: this report pertains to spyscope ds ii complaints and spy ds controller used during the same procedure.Refer to mfr report for the spyscope ds ii and mfr report# 3005099803-2023-06613 for the controller.It was reported to boston scientific corporation that spyscope ds ii complaints and spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and peroral cholangioscopy (poc) procedure for the treatment of indeterminate bile duct stricture performed in the bile duct on (b)(6) 2023.During procedure, spyscope was used a couple of minutes and then the image disappeared.The procedure was not completed due to this event and reschedule.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Manufacturer Narrative

Block h6 (impact codes): 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 was one elevator mark at approximately 36mm was noted 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 in x-ray imaging of the distal cap.No camera wire damage was observed in the pebax region proximal to the working channel sleeve.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 no procedural residue seen near the plastic optic fibers (pof), visual assessment showed no problem with 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.The reported event was not confirmed.During product analysis, a live image was seen upon insertion of the device and after conducting a leak test, no leak was observed; there were no changes to the live image.Based on all gathered information, the probable cause selected is no problem detected, which indicates that the device complaint or problem cannot be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Notes: this report pertains to spyscope ds ii complaints and spy ds controller used during the same procedure.Refer to mfr report# 3005099803-2023-06585 for the spyscope ds ii and mfr report# 3005099803-2023-06613 for the controller.It was reported to boston scientific corporation that spyscope ds ii complaints and spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and peroral cholangioscopy (poc) procedure for the treatment of indeterminate bile duct stricture performed in the bile duct on (b)(6) 2023.During procedure, spyscope was used a couple of minutes and then the image disappeared.The procedure was not completed due to this event and reschedule.There were no reported patient complications 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: 18313518
• MDR Text Key: 330354485
• Report Number: 3005099803-2023-06585
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/13/2024

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: 0032461182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• 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