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

Model Number M00510890

Device Problems Material Too Rigid or Stiff (1544); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the investigation result of side car rx pushed back.Block h10: investigation results: one trapezoid rx lithotripter basket was received for analysis, and a visual inspection observed the sheath was buckled and the side car rx was pushed back.A dimensional test was also performed and confirmed the side car rx was pushed back approximately 3.5 mm, which is out of specification.Additionally, a function test noted the basket opened with some difficulty, as pressure was felt from the buckled sheath.No other issues were noted.The reported event of "basket failure to open" was not confirmed.The buckled sheath and side car rx push back made the basket difficult to open, however it did open.Based on all available information, the side car rx push back and buckled sheath could have occurred due to excessive manipulation when attempting to open the basket.It is possible that the technique used, or the patient's anatomical conditions could have contributed to the event.Therefore, the most probable root cause for the reported failures is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a 3cm trapezoid rx lithotripter basket was used during a lithotripsy procedure performed on october 16, 2023.During the procedure, the basket could not be deployed properly.The procedure was completed with a different device.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.

• 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: 18320510
• MDR Text Key: 330953363
• Report Number: 3005099803-2023-06596
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 0031870853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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