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

Model Number M00546610

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

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

Event Date 11/14/2023

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

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number for the first spyscope ds ii, report number 3005099803-2023-06373 for the second spyscope ds ii and report number 3005099803-2023-06371 for the spy ds controller.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and per-oral cholangioscopy (poc) procedures performed for the diagnosis of stricture in the bile duct on (b)(6) 2023.During the procedure, the first spyscope ds ii malfunctioned after a couple of minutes of usage and then five grey dots appeared across the screen.A second spyscope ds ii was then used; however, no image appeared and went back to the initial start-up screen asking them to connect the device.The spyscope ds ii was unplugged and re-plugged from the spy ds controller, but the image was not displayed.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 18301762
• MDR Text Key: 330353879
• Report Number: 3005099803-2023-06372
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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: 0032407287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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