MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546780

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

Block d2b: pro code ntn.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.

Event Description

It was reported to boston scientific corporation that a spy discover catheter was used during a percutaneous endoscopy procedure performed on (b)(6) 2023.During the procedure, the image of the spy discover catheter kept cutting out while using a non-bsc laser probe.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d2b: pro code ntn.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block h10 the returned spy discover catheter was analyzed, and a visual evaluation noted that there were no forceps marks were noted on the shaft of the catheter.No damage or defect 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.The device was plugged into the controller.A live, clear image was displayed.No problems were observed with physical connectivity of the device.The umbilicus connector was visually inspected and no damage or defects were noted.X-ray imaging of the distal tip showed no problems with the redistribution layer (rdl) or thru-silicon vias (tsvs).X-ray imaging of the handle showed no problems with the printed circuit board assembly (pcba).The device was fully articulated in all directions and no problems were identified with the image.The handle was opened and the components within were visually inspected.It was noted that there was procedural residue on the plastic optical fibers (pofs) and camera wire in the breakout region, indicated procedural fluids had flowed back up the optics lumen into the handle during use.Additionally, the camera wires had corrosion noted, likely from procedural fluid that had flowed back up the optics lumen and made contact with exposed wire in the glue.The tip was blocked and saline was flushed through the irrigation tubing to induce backflow of saline into the optics lumen.When saline reached the handle, it made contact with the exposed camera wires in the glue feature, resulting in a loss of image.The reported complaint was confirmed.Product analysis found that procedural residue remained at the top of the optics lumen in the breakout.Procedural factors can cause this fluid to enter the optics lumen during use and travel to the handle.The fluid from the breakout reached exposed camera wires in the handle, disrupting the image and introducing corrosion.The image signal does not withstand the change in capacitance created by the introduction of saline onto the camera wires.An investigation to address this problem has been completed.Based on all gathered information, the probable cause selected for the image problem due to fluid in the optics lumen 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 spy discover catheter was used during a percutaneous endoscopy procedure performed on (b)(6) 2023.During the procedure, the image of the spy discover catheter kept cutting out while using a non-bsc laser probe.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DISCOVER DIGITAL 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: 17371862
• MDR Text Key: 319878426
• Report Number: 3005099803-2023-03887
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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: 07/13/2023
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0027656954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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