MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546600
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(impact codes): imdrf impact code (b)(4) is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the spyscope ds would not emit light.The procedure was not completed based upon this event.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.
Additional 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 was analyzed, and a visual evaluation noted elevator marks were noted on the shaft of the catheter.An image assessment for visualization was performed.Upon plugging the device into the controller, no image was displayed.Articulation of the catheter had no effect in restoring an image.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).No camera wire damage was observed in x-ray imaging of the distal end.No camera wire damage was observed in the pebax region of the catheter.X-ray imaging of the handle showed potential damage to the camera wires at the breakout region.No damage to camera wires were seen 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.Camera wire damage was seen at the breakout region in the form of a break.Visual assessment showed no problems with the glue feature.The bond of the glue feature to the printed circuit board assembly (pcba) was inspected and 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 effect in restoring an image was seen after these interactions.The reported event was confirmed.During product analysis, it was noted that potential camera wire damage in the breakout region of the catheter was observed.Upon initial insertion of the device, no image was seen.Visual assessment of the camera wires at the breakout region showed that the camera wire became kinked around the steering wires and the plastic optical fibers (pofs).Repetitive articulation during procedure may have caused the steering wires to kink and damage the camera wire.Based on all gathered information, the probable cause for the reported event due to camera wire damage is cause traced to component failure, which indicates that the failure was caused by expected component failure without any design or manufacturing issue specifically the camera wire jacket.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the spyscope ds would not emit light.The procedure was not completed based upon this event.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
• Common Device Name: 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: 16582861
• Report Number: 3005099803-2023-01322
• Device Sequence Number: 4747635
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0030154316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 60 KG