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

Model Number M00510870

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a lithotripsy procedure performed on (b)(6) 2023.During unpacking, the handle cannula was broken.Another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a0501 captures the reportable event of handle cannula was broken.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of handle cannula was broken.Block h10: the returned trapezoid rx device was analyzed, and a visual inspection noted that the device's handle cannula is broken.There are no signs that the device was used in the procedure.The reported complaint is confirmed.Based on all available information, boston scientific corporation concludes that the event of handle cannula break is a known potential risk associated with the use of the device.It is possible that the device was handled incorrectly when opening the pouch/ box which could have led to the handle cannula break.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.During manufacturing, samples are taken from the lot for inspection to verify the devices meet specification.This step of the process would have detected the problem the with handle cannula.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a lithotripsy procedure performed on (b)(6) 2023.During unpacking, the handle cannula was broken.Another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h2: the device code in block h6 was corrected to break a0401.Block h6: device code a0401 captures the reportable event of handle cannula was broken.Block h10: the lithotripter basket was not returned for analysis despite good faith efforts.Photos were provided by the customer that showed the device and corresponding pouch.It is possible to observe that the handle cannula is broken in the device photo.The reported event is confirmed.The broken handle cannula could have been generated due to physician technique, patient anatomy, or device malfunction; however, without analysis of the returned device, the investigation findings do not lead to a clear conclusion about the cause of the reported event.Therefore, the most probable cause of the reported event could not be established.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a lithotripsy procedure performed on (b)(6) 2023.During unpacking, the handle cannula was broken.Another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 17623016
• MDR Text Key: 321977934
• Report Number: 3005099803-2023-04599
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0030976326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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