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

Model Number	M00546550
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter address 2 is (b)(6).Block h6: device code a0501 captures the reportable event that the basket was fractured at its midsection and dislodged into the duodenum.Impact code f2301 captures the foreign body forceps used to retrieve the fractured basket.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the basket was fractured at its midsection and dislodged into the duodenum.A foreign body forceps was used to retrieved the fractured basket.Another same device was used to complete the procedure.There were no 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 the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the basket was fractured at its midsection and dislodged into the duodenum.A foreign body forceps was used to retrieved the fractured basket.Another same device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 2 is (b)(6).Block h6: device code a0501 captures the reportable event that the basket was fractured at its midsection and dislodged into the duodenum.Impact code f2301 captures the foreign body forceps used to retrieve the fractured basket.Block h2: correction to b1 adverse event/product problem.Block a1 patient identifier, and block a2 date of birth has been updated based on the additional information received on september 11, 2025.
Additional Manufacturer Narrative
Block e1: initial reporter address 2 is (b)(6).Block h6: device code a0501 captures the reportable event that the basket was fractured at its midsection and dislodged into the duodenum.Impact code f2301 captures the foreign body forceps used to retrieve the fractured basket.Block h11: the returned spybasket was analyzed, and a product analysis found the basket detached from the catheter.Also, the sheath was observed bent.A destructive test was performed, and part of the sheath was cut.Under microscopic inspection, it was found that the notched hypotube joint had fractured.With all the available information, boston scientific concludes that the reported event of basket detachment of device or device component was confirmed.The basket detachment observed during analysis is most likely due to a random failure of the notched hypotube joint that occurred during the procedure, as confirmed by microscopic inspection (fracture of the notched hypotube).Based on all collected information, the most probable cause is "cause traced to component failure", indicating that a random failure of a device component contributed to the event.Also, the sheath was returned bent.Procedural factors, specifically device handling and the physician's technique (amount of force applied) most likely contributed to the damage observed in the device.That event is catalogued as "adverse event related to procedure" because the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the basket was fractured at its midsection and dislodged into the duodenum.A foreign body forceps was used to retrieved the fractured basket.Another same device was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 23025308
• Report Number: 3005099803-2025-04641
• Device Sequence Number: 9181845
• Product Code: LQR
• UDI-Device Identifier: 08714729965886
• UDI-Public: (01)08714729965886(17)270414(10)36295164
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/22/2025

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: M00546550
• Device Catalogue Number: M00546550
• Device Lot Number: 0036295164
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/27/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/06/2025; 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 60 KG