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

Model Number	M00546550
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used during a procedure performed on (b)(6) 2025.It was reported that the wire got disconnected.It is unknown how the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h11: imdrf device code a0401 captures the reportable event of basket wire break.
Additional Manufacturer Narrative
Block b5 describe event or problem, e1 initial reporter title, e2 health professional, e3 occupation, block g2 report source, ad block h6 impact code has been updated based on additional information received on june 8, 2025.Block h11: imdrf device code a0401 captures the reportable event of basket wire break.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used during a procedure performed on (b)(6) 2025.It was reported that the wire got disconnected.It is unknown how the procedure was completed.There were no patient complications as a result of this event.***additional information received on june 8, 2025*** it was the basket wires that got disconnected but still attached to the device.The problem occurred during an endoscopic retrograde cholangiopancreatography (ercp) procedure inside the patient.The anatomy was the common bile duct.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Block h11: the returned trapezoid rx was analyzed, and it was found that the sheath was kinked and bent.Additionally, the distal part of the sheath was observed damaged.During functional testing, the basket and the wire was observed to be not broken since it was possible to extend and retract the basket.The reported event of basket wire break was not confirmed.Based on all available information, it is most likely that procedure factors such as handling of the device and the force applied by the physician could have caused the damages in the device.The conclusion is acceptable because the adverse event occurred during the procedure, and the device had no influence on the event.This event will be classified as "adverse event related to procedure".Since the basket wires were found not broken, the most probable cause of the reported event basket wire break is "no problem detected".
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used during a procedure performed on (b)(6) 2025.It was reported that the wire got disconnected.It is unknown how the procedure was completed.There were no patient complications as a result of this event.***additional information received on june 8, 2025*** it was the basket wires that got disconnected but still attached to the device.The problem occurred during procedure inside the patient.The anatomy was the common bile duct.The procedure was completed with another same device.
Additional Manufacturer Narrative
E1 (initial reporter email address) has been updated based on the additional information received on october 20, 2025.H6: imdrf device code a0401 captures the reportable event of basket wire break.H11: the returned trapezoid rx was analyzed, and it was found that the sheath was kinked and bent.Additionally, the distal part of the sheath was observed damaged.During functional testing, the basket and the wire was observed to be not broken since it was possible to extend and retract the basket.The reported event of basket wire break was not confirmed.Based on all available information, it is most likely that procedure factors such as handling of the device and the force applied by the physician could have caused the damages in the device.The conclusion is acceptable because the adverse event occurred during the procedure, and the device had no influence on the event.This event will be classified as "adverse event related to procedure".Since the basket wires were found not broken, the most probable cause of the reported event basket wire break is "no problem detected".
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used during a procedure performed on (b)(6) 2025.It was reported that the wire got disconnected.It is unknown how the procedure was completed.There were no patient complications as a result of this event.Additional information received on june 8, 2025: it was the basket wires that got disconnected but still attached to the device.The problem occurred during procedure inside the patient.The anatomy was the common bile duct.The procedure was completed with another same device.

• 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: 22157341
• Report Number: 3005099803-2025-02577
• Device Sequence Number: 12585926
• Product Code: LQR
• UDI-Device Identifier: 08714729965886
• UDI-Public: (01)08714729965886(17)260401(10)33735686
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2025

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 Expiration Date: 04/01/2026
• Device Model Number: M00546550
• Device Catalogue Number: M00546550
• Device Lot Number: 0033735686
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/08/2025; 08/07/2025; 10/20/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/02/2025; 09/02/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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