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

Model Number M00510890

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, upon pulling the handle, the basket did not fully expand.The procedure was completed with another trapezoid rx.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the side car rx was pushed back.Please see block h10 for full investigation details.

Manufacturer Narrative

Block e1: (b)(6).Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx lithotripter basket was received for analysis, and a visual inspection observed that the side car rx was pushed back and the sheath was buckled.The device was filled with remnants of use.A dimensional test confirmed that the side car rx was pushed back approximately 2.5 mm, which is out of specification.Additionally, a functional test was performed by attempting to open the basket, and it was found the basket was only able to open properly after cleaning out the remnants of use inside the device.No other issues were noted.The reported event was confirmed.The results of the analysis performed showed that the basket wasn't opening at all initially when using the handle.After the remnants of use were cleaned, the basket was able to open without any major difficulties.The sheath was also found buckled, which could have happened as a result of the force applied on the handle by trying to open the basket.The side car rx may also be affected when excessive force is applied to the handle.In this case, since the basket wasn't being opened and was stuck, this pressure affected the side car rx causing it to push back.Therefore, the most probable root cause for the reported issue and the issues found during analysis is adverse event related to procedure.

• Brand Name: TRAPEZOID RX
• Type of Device: 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: 18503303
• MDR Text Key: 333157347
• Report Number: 3005099803-2023-07066
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031845038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1