MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number	M00510890
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: block a0401 captures the reportable event of handle cannula break.Block a23 captures the reportable event of basket failure to crush stone.Block a051104 captures the reportable event of basket failure to release stone.Block a150207 captures the reportable event of device difficult to remove.Block f2301 captures the event that the impacted basket was removed with a sohendra lithotripsy system.Block f23 captures the event that a series of emergency operations was performed to remove the impacted basket.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during a biliary tract stone removal by endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the basket was advanced into the patient's bile duct to capture a stone.While the physician attempted to crush the stone using an alliance handle, the handle cannula of the trapezoid rx handle fractured and the basket was unable to crush stone.The stone was stuck in the basket, and the basket could not be removed from the bile duct.After a series of emergency operations, the impacted basket was finally removed with a sohendra lithotripsy system.The procedure was completed using another trapezoid rx.There were no patient complications as a result of this event, and the patient's condition following procedure is stable.
Additional Manufacturer Narrative
Block h6:\ block a0401 captures the reportable event of handle cannula break\ block a23 captures the reportable event of basket failure to crush stone\ block a051104 captures the reportable event of basket failure to release stone\ block a150207 captures the reportable event of device difficult to remove\ block f2301 captures the event that the impacted basket was removed with a sohendra lithotripsy system\ block f23 captures the event that a series of emergency operations was performed to remove the impacted basket.\ \ block h11:\ the device was not returned for analysis despite good faith efforts to obtain product return; therefore, a technical analysis could not be performed.The customer provided a picture where it can be observed the device with the handle actuated.Also, the evidence provided by the customer was limited and does not provide any additional details to the device analysis.\ \ 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 \"handle cannula break\", \"basket failure to crush stone\", \"basket failure to release stone\", \"device difficult to remove\", \"additional device required\" and \"unexpected medical 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 issues \"handle cannula break\", \"basket failure to crush stone\", \"basket failure to release stone\" and \"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.The customer provided a picture where it can be observed the device with the handle actuated.However, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.On the other hand, for the events additional device required and unexpected medical 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.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during a biliary tract stone removal by endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.\ \ during the procedure, the basket was advanced into the patient's bile duct to capture a stone.While the physician attempted to crush the stone using an alliance handle, the handle cannula of the trapezoid rx handle fractured and the basket was unable to crush stone.The stone was stuck in the basket, and the basket could not be removed from the bile duct.After a series of emergency operations, the impacted basket was finally removed with a sohendra lithotripsy system.The procedure was completed using another trapezoid rx.\ \ there were no patient complications as a result of this event, and the patient's condition following procedure is stable.

• 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 ; 9145716918
• MDR Report Key: 25243927
• Report Number: 3005099803-2026-02011
• Device Sequence Number: 13387129
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)261205(10)38117672
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040447
• 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): 07/13/2026

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
• Device Lot Number: 0038117672
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 12/05/2025
• 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: Unknown