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

Model Number M00510890

Device Problems 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 07/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The returned trapezoid basket was analyzed, and a visual evaluation observed that the handle cannula was detached.Due to the handle cannula detachment, the device has lost its functionality, so it is not able to activate the basket.Dimensional inspection confirmed the side car rx was pushed back approximately 3.0 mm which is out of specification.In addition, the handle cannula has a slight mark of the proximal fastening screw.The depth of the fastening screws was measured, and it was within the allowed tolerance.The length of the fastening screws was measured, and the proximal screw was less than the allowed tolerance.Microscope inspection noted that the proximal screw has a flat tip.The reported event was confirmed.Based on all available information, it was determined that the most likely cause is attributable to the supplier.Due to the condition of the screw, the proper fastening is not given (even if the screws had the appropriate depth), so the force applied when activating the device causes the detachment of the handle cannula leaving slight drag marks of the screws on it.Therefore, the most probable root cause of the issue handle cannula detached is manufacturing deficiency; an investigation is underway to address this problem.The side car rx pushback could have been a consequence of the manipulation or the detachment of the handle cannula.Therefore, the cause code is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with choledocholithiasis and mechanical lithotripsy procedure performed on (b)(6) 2022.During the procedure, the trapezoid rx basket was attached to an alliance inflation device for lithotripsy, however, the basket wires were not opening and closing easily.The basket was then removed from the patient and upon checking, found that the basket wires were not opening and closing.The device was removed, and the procedure was completed with an olympus mechanical lithotripter.There were no patient complications reported as a result of this event.Investigation results revealed the handle cannula detached/separated and the side car rx was pushed back; therefore, this is now an mdr reportable 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: 15974577
• MDR Text Key: 308155208
• Report Number: 3005099803-2022-07331
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029264969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 68 KG