MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER; DISLODGER, STONE, BILIARY

Model Number	M00542990
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a spyglass discover was used in the cystic duct during a laparoscopic common bile duct exploration (lcbde) discover procedure performed on (b)(6) 2025.During procedure, a discover basket was used with a spycope to attempt to remove a stone.However, the stone was too large to be remove from the duct and got stuck inside the basket.There were no visible damage noted on the basket.The patient was then converted to open surgery.The basket was disassembled to remove the scope off.The stone was successfully removed from the basket.The basket and stone was successfully removed.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass discover was used in the cystic duct during a laparoscopic common bile duct exploration (lcbde) discover procedure performed on (b)(6) 2025.During procedure, a discover basket was used with a spycope to attempt to remove a stone.However, the stone was too large to be remove from the duct and got stuck inside the basket.There were no visible damage noted on the basket.The patient was then converted to open surgery.The basket was disassembled to remove the scope off.The stone was successfully removed from the basket.The basket and stone was successfully removed.Additional information received on february 7, 2025.The size of the stone was approximately 5-6mm.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f19 captures the reportable event of surgical intervention.Block h2: block b5 has been updated based on the additional information received on february 7, 2025.Correction to field g1 mfr site facility name, mfr site address 1, mfr site city, mfr site zip/post code, and mfr site country.

• Brand Name: SPYGLASS DISCOVER
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21335233
• Report Number: 3005099803-2025-00320
• Device Sequence Number: 14392425
• Product Code: LQR
• UDI-Device Identifier: 00191506004255
• UDI-Public: 00191506004255
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: M00542990
• Device Catalogue Number: M00542990
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White