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

Model Number	M00510870
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the contrast medium flowed back and leaked from the basket handle wire.Another trapezoid rx was used to complete the procedure.There were no patient complications as a result of this event.Note: this event has been deemed a reportable event based on the investigation finding of side car rx pushback.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx was analyzed, and a visual inspection found the side car rx was pushed back approximately 4 mm and device was leaking water from the handle.In the video submitted by the customer, it can be seen that the handle leaked.Based on all available information, the side car rx push back could have occurred due to excessive manipulation trying to open the basket or attempting to crush the stone.It is often seen that the side car is affected when excessive force is applied to the handle to open the basket.This was most likely also caused due to the amount of force applied on the thumb ring from the handle when trying to destroy the stone, and by this force applied, the working length tends to "retract" itself and therefore, pushing back the side car rx.Therefore, the conclusion code for the investigation finding of side car rx push back is adverse event related to procedure.However, the device was taken to x-ray to determine if there was something inside the handle that could be affecting the device and making this backflow.However, it was seen that inside the handle the spacer and the o ring are on position.Therefore, the most probable root cause for the reported event of handle leak 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19015382
• Report Number: 3005099803-2024-01262
• Device Sequence Number: 8162644
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2024
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0032106229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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
• Patient Sex: Unknown