MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546600
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spyscope digital access & delivery catheter was used during an endoscopic retrograde cholangiopancreatography(ercp) procedure performed for the treatment of bile duct stones in the bile duct on (b)(6) 2024.During the procedure, the catheter could not be recognized after it was connected to the console.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).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 was analyzed and found that the scope was not able to display an image.The reported complaint was confirmed.During product analysis, the x-ray images of the distal tip observed lifting of the camera wires at the redistribution layer (rdl).The visualization problem is most likely that the camera wires lifted from the rdl, due to mechanical forces applied to the camera wire.This could have happened when the device was assembled or during tip articulation.Based on all gathered information, the probable cause selected for the image failure cause traced to component failure, which indicates that a random problem with a device component contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope digital access & delivery catheter was used during an endoscopic retrograde cholangiopancreatography(ercp) procedure performed for the treatment of bile duct stones in the bile duct on (b)(6) 2024.During the procedure, the catheter could not be recognized after it was connected to the console.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

• Brand Name: SPYSCOPE DS
• Common Device Name: 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: 20014870
• Report Number: 3005099803-2024-03955
• Device Sequence Number: 15268376
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0031368831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 86 KG