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

Model Number	M00510860
Medical Device Problem Codes	Premature Activation (1484); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a15010 captures the reportable event of tip premature deployment.Imdrf device code a0501 captures the reportable event of basket detachment.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the cbd stone during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, prior to capturing the stone, the basket detached.The basket was removed from the patient; however, the basket tip was left inside the patient.The procedure was completed with another trapezoid rx basket.No known patient complications were reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the cbd stone during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, prior to capturing the stone, the basket detached.The basket was removed from the patient; however, the basket tip was left inside the patient.The procedure was completed with another trapezoid rx basket.No known patient complications were reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15010 captures the reportable event of tip premature deployment.Imdrf device code a0501 captures the reportable event of basket detachment.Block h11: the returned trapezoid rx was analyzed, and a product analysis found the basket tip was not returned.The basket was attached to the pull wire as intended.The side car rx was found pushed back 2 mm.No other issues were noted.The reported event of tip premature deployment was confirmed.Based on all available information, it is most likely that the side car rx push back was due to the physician's technique when manipulating the handle from the basket.It was reported that the basket was detached; however, the part detached was the tip.Since the side car was found pushed back, this could also mean that the thumb ring was retracted at some point during the procedure.If it was retracted with excessive force, this could have detached the basket tip.Therefore, the most probable root cause is adverse event related to procedure.Since the reported event of basket detachment of device or device component couldn't be seen during the analysis, that reported event will be addressed as no problem detected.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20102499
• Report Number: 3005099803-2024-04094
• Device Sequence Number: 20768078
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/22/2024

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: 05/08/2025
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 0033988105
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown