MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Trapezoid RX; lithotriptor, biliary mechanical

Model Number	M00510890
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
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 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 patient code e2008 captures the reportable event of the trapezoid rx stuck in the common bile duct.Imdrf impact code f19 captures the reportable event of the patient being taken to the operating room for emergent device removal.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic procedure performed on (b)(6) 2026.During the procedure, the trapezoid rx became stuck in the common bile duct after multiple attempts to remove the device.The duodenoscope was withdrawn while the device remained in the patient.The wire was cut and secured to the patient's cheek, and the patient was subsequently taken to the operating room for emergent device removal.No additional patient complications or adverse outcomes were reported.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic procedure performed on (b)(6) 2026.During the procedure, the trapezoid rx became stuck in the common bile duct after multiple attempts to remove the device.The duodenoscope was withdrawn while the device remained in the patient.The wire was cut and secured to the patient's cheek, and the patient was subsequently taken to the operating room for emergent device removal.No additional patient complications or adverse outcomes were reported.
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 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 patient code e2008 captures the reportable event of the trapezoid rx stuck in the common bile duct.Imdrf impact code f19 captures the reportable event of the patient being taken to the operating room for emergent device removal.Block h11: the complaint device was not returned therefore, product analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the events of "device difficult to remove and surgical intervention" were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information provided, the most probable cause of the reported issue "device difficult to remove" cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.On the other hand, for the events unretrieved device fragments (udf) and surgical intervention, they happened during the procedure, and the most probable cause of those reported issues cannot be established due to lack of evidence.For this reason, they will be classified as cause not established.All compiled information on this investigation determines that the most probable cause is cause not established.

• Brand Name: Trapezoid RX
• Common Device Name: lithotriptor, biliary mechanical
• 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 ; +1(914)571-6918
• MDR Report Key: 25694497
• Report Number: 3005099803-2026-02652
• Device Sequence Number: 13179030
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040447
• 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): 07/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00510890
• Device Catalogue Number: M00510890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/30/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown