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

Model Number M00546610

Device Problem Difficult to Advance (2920)

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

Event Date 03/11/2024

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

It was reported to boston scientific corporation that a spyscope ds ii was used in cholangioscopy procedure performed in the pancreatic duct for the treatment of pancreatic duct stones on (b)(6) 2024.During the procedure, the ehl was unable to pass through the spyscope ds ii.The ehl probe kept getting stuck when the spyscope was in the straightened state.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The device was not return.

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 signs of use in the form of elevator marks 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 steering wheel at the handle and had no effect on image.The working length of the catheter was fed through a passability fixture.An ehl probe was used to test for passability.The ehl probe was fed through the working channel port at the handle and was able to come out of the distal end.The handle was opened, and the inside was visually inspected, no problems were noted with the inside of the device handle.The reported event was not confirmed.During product analysis, visual inspection of the device exterior did not identify any damage or defect that could have contributed to difficulty to advance accessories.An ehl probe was fed through the working port of the device while the working length was inside a passability fixture.The ehl probe was seen leaving the distal end of the catheter and was able to be fed through the catheter with no problems.Signs of use were noted with the returned device in the form of elevator marks.It is likely that factors of the procedure such as use of a combination device and tortuous anatomy may have attributed to the observed difficulty in advancing accessories.Based on all gathered information, the probable cause selected for the reported difficulty in advancing accessories issue is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii was used in cholangioscopy procedure performed in the pancreatic duct for the treatment of pancreatic duct stones on (b)(6) 2024.During the procedure, the ehl was unable to pass through the spyscope ds ii.The ehl probe kept getting stuck when the spyscope was in the straightened state.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The device was not return.

• 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: 19011725
• MDR Text Key: 339033763
• Report Number: 3005099803-2024-01381
• Device Sequence Number: 1
• Product Code: FBN
• 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: 05/28/2024

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: 0032976922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2023
• 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