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

Model Number	M00546610
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block h11: investigation results the complaint device was not returned; therefore, product analysis could not be performed.As a result, and due to insufficient evidence, the reported event cannot be confirmed.A risk review of the spyscope ds ii device verified that the event category cancelled/rescheduled - post sedation/sedation unknown is defined within the risk documentation and properly recorded in the prr.This event type was considered during the products risk analysis to ensure an acceptable risk-benefit profile.The evaluation includes both the severity and frequency of risks, and the overall residual risk of the spyscope ds ii device is considered acceptable.Based on the available information, a probable root cause for the reported issue cannot be determined due to the lack of evidence.Because the product was not returned for analysis, it was not possible to assess for potential defects.Without a thorough evaluation of the device, no contributing factors to the event can be conclusively identified.The impact code cancelled/rescheduled - post sedation/sedation unknown will be addressed as adverse event related to procedure since the event was not completed due to the conditions faced during the procedure.All compiled information on this investigation determines that the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii was attempted for use in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2026, for the treatment of bile duct tumor.During the procedure, the spybite biopsy forceps are unable to pass through the working channel of the spyglass.The procedure was not completed due to this event.No patient complications were reported as a result of this event.

• Brand Name: SPYSCOPE? DS II
• 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 ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24876137
• Report Number: 3005099803-2026-01359
• Device Sequence Number: 15957397
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)270527(10)40330729
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183636
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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 Model Number: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 0040330729
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 05/27/2025
• 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 Sex: Unknown