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

Model Number M00546610

Device Problem Positioning Problem (3009)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed for the treatment of cholelithiasis on (b)(6) 2023.During the procedure, while performing the electrohydraulic lithotripsy, one of the two control knobs of the spyscope ds ii was blocked.There was difficulty articulating the scope tip to direct the probe in breaking the gallstones.The ercp was unable to be completed as a result of this event.An advanix biliary stent was placed and a follow-up procedure was planned for a continuous treatment of the patient.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed for the treatment of cholelithiasis on (b)(6) 2023.During the procedure, while performing the electrohydraulic lithotripsy, one of the two control knobs of the spyscope ds ii was blocked.There was difficulty articulating the scope tip to direct the probe in breaking the gallstones.The ercp was unable to be completed as a result of this event.An advanix biliary stent was placed and a follow-up procedure was planned for a continuous treatment of the patient.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: 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.One elevator mark was noted on the shaft of the catheter.An image assessment was performed and a live image was seen upon insertion of the device umbilicus into the controller.Articulation of the catheter working length was conducted using the small knob of the steering wheel at the handle.The small knob was unable to turn in any directions; the working length of the catheter did not articulate.The articulation test was continued using the large knob of the steering wheel and the catheter was able to be articulated.The large knob was able to be turned in both clockwise and counterclockwise directions.The device handle was opened and the inside was visually inspected.Visual inspection of the steering wires noted one steering wire was out of position; the steering wire was noted to be on top of the pulley.The steering wire was then rerouted to be in its normal position (i.E.In line with the pulley).The handle was closed and an articulation test was performed again with the small knob of the steering wheel.The working length was able to be articulated and the small knob was able to be turned in both the clockwise and counterclockwise directions.The reported complaint was confirmed.Based on all gathered information, boston scientific concludes that the probable cause of articulation problem is traced to component failure, which indicates that a random failure with a device component contributed to the event.Manufacturing processes ensure that steering wires inside the handle are properly positioned and tensioned, and final inspection confirms articulation of the device.As there were no manufacturing deviations noted, the articulation problem is most likely due to a random failure of the steering wire to maintain its position along the pulley.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: 18446072
• MDR Text Key: 331936789
• Report Number: 3005099803-2023-06904
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/26/2024

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: 0032285288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• 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