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 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f05 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 during a cholangiolithotripsy procedure performed in the bile duct on (b)(6) 2023.During the procedure, the century electrohydraulic lithotripsy (ehl) probe was unable to cross through the scope and it did not protrude from the scope.The procedure was not completed and reschedule.It was reported that the procedure was completed on (b)(6) 2023.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 was used during a cholangiolithotripsy procedure performed in the bile duct on (b)(6) 2023.During the procedure, the century electrohydraulic lithotripsy (ehl) probe was unable to cross through the scope and it did not protrude from the scope.The procedure was not completed and reschedule.It was reported that the procedure was completed on (b)(6) 2023.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 impact codes: imdrf impact code f05 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 signs of use in the form of elevator marks on the shaft of the catheter.No damage or defect was noted on the tip of the device or the working channel.Witness marks were observed on the contacts of the umbilicus connector, indicating it was connected to a controller.A functional assessment of accessory passability was performed.Testing was conducted with an autolith ehl probe.First, the spyscope was introduced into an articulation fixture to test for passability no problem were observed and the spyscope passed freely.The ehl probe was passed through the spyscope in a straight configuration and no difficulty was observed.The probe passed freely.The probe was removed from the device with no problem observed.The spyscope device was placed in an articulation fixture and a functional assessment was repeated by passing the ehl probe through the device.The probe passed freely.The ehl probe was removed from the device with no problem observed.The reported complaint was not confirmed.Product analysis was unable to replicate or identify any problem that could have caused or contributed the reported event.No damage was noted on the spyscope during analysis, it appeared used.Accessories passed normally.It is possible that tortuosity of the anatomy contributed to difficulty passing the accessory, or that damage to accessories unrelated to interaction with the spyscope caused problem with passability.Its possible handling of accessories or technique during use also contributed.Both of those possible scenarios are do not involve contribution from the spyscope device.Based on all gathered information, the complaint investigation conclusion code selected for the accessory problem is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.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: 17371724
• MDR Text Key: 319510656
• Report Number: 3005099803-2023-03866
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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: 0031028790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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