MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER; Choledochoscope and accessories, flexible/rigid

Model Number M00546780

Device Problem Optical Problem (3001)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

Block d2 (pro code): ntn.Block h6 (impact codes): imdrf impact code f05 is being used to capture the reportable event of delay to treatment/therapy.

Event Description

It was reported to boston scientific corporation that spy discover catheter complaint was used during percutaneous cholangioscopy for the treatment of gallstones performed in the gallbladder on (b)(6) 2024.During the procedure, when the scope and basket were used to remove gallstones from the gallbladder, the 3 dots appeared on the screen, and they lost visualization from the scope.The procedure was not completed and rescheduled on (b)(6) 2024.There were no reported patient complications as a result of this event.

• Brand Name: SPYGLASS DISCOVER DIGITAL 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: 18888500
• MDR Text Key: 337511763
• Report Number: 3005099803-2024-00837
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

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: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0032268294
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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