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

Model Number M00546600

Device Problems Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a spyscope ds was used during an intrahepatic bile duct probing procedure performed on (b)(6) 2022.During procedure, the spyscope ds screen flickered severely and could no longer used.The procedure was not completed due to this event.The patient's condition was reported to be stable.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a spyscope ds was used during an intrahepatic bile duct probing procedure performed on (b)(6) 2022.During procedure, the spyscope ds screen flickered severely and could no longer used.The procedure was not completed due to this event.The patient's condition was reported to be stable.

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 was performed.Elevator marks were noted on the shaft of the catheter.Upon plugging the device into the controller, no live image was seen.The device was fully articulated in all directions.There was no impact to the image was seen.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl).Potential camera wire damage was observed near the distal end in the form of a break.No camera wire damage was observed in the pebax region of the catheter.X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba) or camera wire damage in the handle and around the strain relief.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 problems with the camera wires near the pcba.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 complaint was confirmed.During product analysis, the condition of the wires suggests a lack of controls regarding camera wire handling during the manufacturing process (likely during camera/pof potting, stuffing, and/or pof bonding), resulting in nicked insulation of the camera wires and twisting of wires.Process controls were implemented on the manufacturing line to minimize the occurrence of this failure.This included additional visual inspections and new tooling that had less blunt edges that could nick the insulation of the camera wire.It is likely that the damage to the camera wire, as well as handling of the device during procedure, created a break in connection of the camera during the procedure, which then caused the reported visualization issue.Based on all gathered information, the probable cause for the visualization issue due to distal camera wire damage is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.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
• 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: 15924017
• MDR Text Key: 308152370
• Report Number: 3005099803-2022-07175
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0029824328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG