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

Model Number	M00510870
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a23 captures the reportable event of basket failure to crush stone.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a trapezoid rx was used for choledocholithiasis in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, a trapezoid rx basket was used to remove a 14 mm stone.The basket wires were successfully placed around the stone; however, it could not crush the stone.They tried to pull the basket out of the bile duct, but it got stuck in the bile duct.An alliance handle was used to detach the tip of the basket, but it was not successful.The patient underwent exploratory surgery with bile duct exploration on the same day and the basket and stone were removed successfully.The patient was admitted beyond standard of care and was expected to fully recover.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a trapezoid rx was used for choledocholithiasis in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, a trapezoid rx basket was used to remove a 14 mm stone.The basket wires were successfully placed around the stone; however, it could not crush the stone.They tried to pull the basket out of the bile duct, but it got stuck in the bile duct.An alliance handle was used to detach the tip of the basket, but it was not successful.The patient underwent exploratory surgery with bile duct exploration on the same day and the basket and stone were removed successfully.The patient was admitted beyond standard of care and was expected to fully recover.
Additional Manufacturer Narrative
Block h2: correction block h6 (device codes) have been updated.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a23 captures the reportable event of basket failure to crush stone.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Block h11: based on the available information and the photo attached by the complainant, boston scientific confirmed the reported event of tip failure to separate and side car rx push back.However, the reported events of basket failure to crush stone and device difficult to remove with the evidence provided.The device was not returned for analysis; therefore, a thorough investigation of the device could not be performed.It was confirmed this device met manufacturing specifications 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 basket failure to crush stone, tip failure to separate, side car rx push back, surgical intervention, and hospitalization or prolonged hospitalization were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on all available information and a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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 ; 9145716918
• MDR Report Key: 19740459
• Report Number: 3005099803-2024-03294
• Device Sequence Number: 15397618
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K040447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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 Expiration Date: 11/26/2024
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0032933564
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 11/27/2023
• 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: Other; Hospitalization
• Patient Sex: Unknown