MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SpyGlass Discover; choledochoscope and accessories, flexible/rigid

Model Number	M00546780
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6:\ imdrf code a150101 captures the reportable event of detachment of device or device component\ imdrf code f23 captures the reportable event of unexpected medical intervention\ \ investigation summary\ the spy discover catheter was not returned.Therefore, the reported events of \"unretrieved device fragments (udf)\" and \"unexpected medical intervention\" could not be confirmed due to the lack of evidence.\ it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.\ a similar complaint review was completed.There were no emerging trends identified that warrant further action.\ based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Additional Manufacturer Narrative
Block h6:\ imdrf code a150101 captures the reportable event of detachment of device or device component;\ imdrf code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a spy discover catheter was utilized in a lcbde (laparoscopic common bile duct exploration) procedure on (b)(6) 2026 for treatment of stones in the common bile duct.\ \ during the procedure, a piece of the light blue covering at the distal end of the spyglass discover catheter had chipped off into the patient abdomen.The physician performed an an exploratory laparotomy for small bowel resection however was not able to locate the piece that chipped off.Patient is scheduled for a follow up visit.\ \ procedure was completed with the original device.\ \ no other patient complications were reported as a result of the event.
Event or Problem Description
It was reported to boston scientific corporation that a spy discoverer catheter was utilized in a lcbde (laparoscopic common bile duct exploration) with spyglass discover on (b)(6) 2026.\ \ during the procedure, a piece of the light blue covering at the distal end of the spyglass discover catheter had chipped off into the patient abdomen.The physician performed an an exploratory laparotomy for small bowel resection however was not able to locate the piece that chipped off.Patient is scheduled for a follow up visit.\ \ procedure was completed with the original device.\ \ no other patient complications were reported as a result of the event.

• Brand Name: SpyGlass Discover
• 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; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50882077
• Report Number: 3005099803-2026-03928
• Device Sequence Number: 18830072
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00546780
• Device Catalogue Number: M00546780
• Device Lot Number: 0040460176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/21/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown