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); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass digital controller were used during the biliary lithotripsy procedure performed on (b)(6), 2023.During the procedure, after the stone was crushed with electrohydraulic lithotripsy (ehl), the plastic stent migrated.They tried to retrieve it with spybite or spy basket; however, the image got distorted and then disappeared.The spyscope ds ii was removed from the endoscope, and the screen display appeared as if the problem was resolved.The spyscope ds ii was inserted again into the endoscope, but the same problem occurred.The procedure was not completed due to this event and was rescheduled for another day.There were no patient complications reported 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.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.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.Upon plugging the device into the controller, no image was displayed.No problems were observed with the physical connection of the device.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl) or thru-silicon vias (tsvs).It was noted that the camera wire was damaged at the distal cap/steering ring.X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba) or camera wires inside the handle.Leak testing was performed with the unit using saline the unit was pressurized by injecting fluid through the irrigation tubing of the device with the tip inserted into a mock-cbd fixture and pressure did not change.No leak was observed during testing.The reported complaint regarding visualization was confirmed.During product analysis, the device was found camera wire damage at the distal tip.The condition of the wires suggests a lack of controls regarding camera wire handling during the manufacturing process (likely during camera/plastic optical fiber (pof) potting, stuffing, and/or plastic optical fiber (pof) bonding), resulting in nicked insulation of the camera wires and/or 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.The failure mode is monitored as part of the post market signal evaluation and escalation process and will be escalated should an excursion be observed.Based on all gathered information, the probable cause selected for the visualization problems due to 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.

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass digital controller were used during the biliary lithotripsy procedure performed on (b)(6) 2023.During the procedure, after the stone was crushed with electrohydraulic lithotripsy (ehl), the plastic stent migrated.They tried to retrieve it with spybite or spy basket; however, the image got distorted and then disappeared.The spyscope ds ii was removed from the endoscope, and the screen display appeared as if the problem was resolved.The spyscope ds ii was inserted again into the endoscope, but the same problem occurred.The procedure was not completed due to this event and was rescheduled for another day.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: 17702537
• MDR Text Key: 322883496
• Report Number: 3005099803-2023-04694
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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: 0031982668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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