MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SpyScope DS II; Choledochoscope And Accessories, Flexible/Rigid

Model Number	M00546610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	08/28/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to boston scientific corporation that a spyglass procedure with biopsy was performed on (b)(6) 2026 at approximately 9:00 am at (b)(6).The procedure involved exploration of the bile ducts using one spyscope and biopsy of the bile duct walls using one spybite max.The procedure was requested by endoscopist ana alicia rosales solis and was performed in the outpatient procedure room without an autolite console or probe.The physician initiated the ercp using an olympus duodenoscope and sphincterotome, with the assistance of two endoscopy technicians and one resident physician.After sphincterotomy, the spyscope was prepared by flushing the working and irrigation channels with saline and connecting the irrigation channel to a water pump.The spyglass console and illumination were activated, and video recording was confirmed.The bile ducts were successfully examined with the spyscope, and no bleeding was observed.The physician then requested the spybite max to obtain biopsies of the bile duct walls.The biopsies were completed without reported complications.After the final biopsy, the physician noticed that the patient had developed a blue discoloration and informed the anesthesiologist that the patient was desaturating.The duodenoscope was immediately removed to allow resuscitation efforts to begin.The technician removed the spyscope and spyglass equipment from the room and remained available outside while resuscitation was performed for approximately 40 minutes however, the patient did not survive.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii was used during an endoscopic retrograde cholangiopancreatography (ercp) with biopsy collection on (b)(6) 2026 for treatment of indeterminate stricture.The physician initiated the ercp using a duodenoscope and sphincterotome, with the assistance of two endoscopy technicians and one resident physician.After sphincterotomy, the spyscope was prepared by flushing the working and irrigation channels with saline and connecting the irrigation channel to a water pump.The spyglass console and illumination were activated, and video recording was confirmed.The bile ducts were successfully examined with the spyscope, and no bleeding was observed.The physician then requested the spybite max to obtain biopsies of the bile duct walls.The biopsies were completed without complications.After the final biopsy, the physician noticed that the patient had developed a blue discoloration and informed the anesthesiologist that the patient was desaturating.The duodenoscope was immediately removed to allow resuscitation efforts to begin.Cardiopulmonary resuscitation was performed for approximately 40 minutes however, the patient did not survive.
Additional Manufacturer Narrative
Block h6: imdrf patient code eo742 captures the reportable event of respiratory failure.Imdrf impact code f2306 captures the reportable event of resuscitation.Imdrf impact code f02 captures the reportable event of patient's death.Block h11: correction made to b5 describe event or problem.
Additional Manufacturer Narrative
Block h6: imdrf patient code eo742 captures the reportable event of respiratory failure.Imdrf impact code f2306 captures the reportable event of resuscitation.Imdrf impact code f02 captures the reportable event of patient's death.

• 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 ; +1(914)571-6918
• MDR Report Key: 50923454
• Report Number: 3005099803-2026-03946
• Device Sequence Number: 5394301
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)280401(10)40453868
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 0040453868
• 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: 09/22/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/02/2026
• 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: Death
• Patient Sex: Unknown