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

Model Number M00510880

Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Device code a0406 captures the reportable investigation finding of side car-rx pushback.The returned trapezoid rx basket was analyzed, and it was observed that the side car-rx was torn and pushed back out of specification, approximately 2.0mm.The working length has the sheath buckled and separated.No other issues noted.The reported event is confirmed.Based on all available information, due to the buckled and separated sheath that affects the functionality to extend the basket, and the presence of some remnants of use, it is possible that the unit was subjected to excessive manipulation during the procedure; perhaps the technique used, or patient's anatomical conditions could have contributed to the reported event.Therefore, the most probable root cause is adverse event related to procedure.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2023.During procedure, after the first stone was crushed using a trapezoid rx basket, however, in an attempt to open the basket inside the patient for another crushing, basket could not be opened.The basket was then removed from the patient and checked.It was found that the basket was difficult to open outside the patient, and no other device problem was noted.The basket was then reinserted, and another attempt was made to open the basket, however, it could not be opened; therefore, another trapezoid rx was used to complete the procedure.There were no patient complications as a result of this event.The investigation results revealed that the side car-rx was pushed back; therefore, this is now an mdr reportable event.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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16512720
• MDR Text Key: 311214307
• Report Number: 3005099803-2023-01276
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• 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
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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