MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS? RETRIEVAL BASKET; DISLODGER, STONE, BILIARY

Model Number	M00546550
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: initial reporter phone number: (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of a canceled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in pancreatic duct during a cholangioscopy procedure on (b)(6) 2025.During the procedure, the patient was sedated, and the spybasket was inserted into the working channel but could not be advanced.The scope was removed from the pancreatic duct, and it was impossible to retrieve the basket.The procedure was not successfully completed due to the prolonged examination time.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in pancreatic duct during a cholangioscopy procedure on (b)(6) 2025.During the procedure, the patient was sedated, and the spybasket was inserted into the working channel but could not be advanced.The scope was removed from the pancreatic duct, and it was impossible to retrieve the basket.The procedure was not successfully completed due to the prolonged examination time.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: initial reporter phone number: (b)(6).Block h2: correction.Correction to the initial reporter phone number.Block h6: imdrf impact code f1001 captures the reportable event of a canceled procedure.Block h11: investigation results the spybasket was returned for analysis.The device was returned with the sheath bent.However, during functional test it was possible to introduce and retrieve the device from a spyscope ds ii.Based on the available information, the investigation findings were it is not possible to determine whether the device used during the procedure (scv-p-02g) had any damage or restriction that wouldn't have allowed the spybasket to pass through the working channel.In addition, the sheath was observed bent, most likely procedural factors as handling of the device and the technique used by the physician (force applied), could have resulted in the damage encountered in the device.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.

• Brand Name: SPYGLASS? RETRIEVAL BASKET
• 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 IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22871825
• Report Number: 3005099803-2025-03918
• Device Sequence Number: 10371114
• Product Code: LQR
• UDI-Device Identifier: 08714729965886
• UDI-Public: (01)08714729965886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071066
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: M00546550
• Device Catalogue Number: M00546550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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