MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

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 08/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheter were used during an endoscopic retrograde cholangiopancreatography (ercp) with cholangioscopy procedure performed on (b)(6) 2023.During the procedure, the visualization from the spyscope ds ii was lost.A second spyscope ds ii was used, and the same problem occurred.The procedure was not completed due to this event.It was reported that the follow up procedure was successfully completed.The exact date is unknown.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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

Event Description

Note: this report pertains to two spyscope ds ii devices used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheter were used during an endoscopic retrograde cholangiopancreatography (ercp) with cholangioscopy procedure performed on (b)(6) 2023.During the procedure, the visualization from the spyscope ds ii was lost.A second spyscope ds ii was used, and the same problem occurred.The procedure was not completed due to this event.It was reported that the follow up procedure was successfully completed.The exact date is unknown.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 was performed.Elevator marks were noted 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.X-ray imaging of the distal tip showed no issues with the redistribution layer (rdl), camera wires, or thru-silicon vias (tsvs).X-ray imaging of the handle showed no issues with the printed circuit board assembly (pcba) inside the handle.An image assessment for visualization was performed.The device was plugged into the controller.A live, clear image was displayed.No issues were observed with physical connectivity of the device.The umbilicus connector was visually inspected, and no damage or defects were noted.The device was fully articulated in all directions; no issues were identified with the image; no issues 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 pofs and camera wire in the breakout region, indicated procedural fluids had flowed back up the optics lumen into the handle during use.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 dropped immediately, indicating a leak path into the optics lumen.The external shaft was wrapped in ptfe tape to test external leakage and the test was repeated.The leak was no longer present, and the unit held pressure.Image was lost during leak testing.The reported complaint was confirmed.The optics lumen in the shaft of the catheter is the portion of the device where the camera wire is routed from the tip to the handle.With the introduction of saline to the optics lumen, a capacitance is added to the camera signal that affects the electrical properties and can disrupt the image.Couplers are in place internal to the device to seal distal joints of the optics lumen at the pof and mle joints.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 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: 17649815
• MDR Text Key: 322263695
• Report Number: 3005099803-2023-04653
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 10/20/2023

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: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0031316845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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