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

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Visual inspection of the returned device found the thumb ring was detached from the handle.The handle has coincident marks that indicate proper assembly during manufacturing.The working length was found kinked, the sheath was torn/buckled and the side car rx tunnel was torn.Based on all available information, the investigation concluded that procedural or anatomical factors encountered during the procedure likely affected the device's performance and integrity.Handling and manipulation of the device during its use can lead to thumb ring detachment.Drag marks were observed which indicate that an excessive force was applied to the handle to crush the stone resulting in thumb ring detachment.Forces applied to the handle can also lead to the kinks in the working length, sheath torn/buckled and side car rx tunnel torn.Therefore, the most probable root cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.

Event Description

Boston scientific corporation received a returned device of a trapezoid rx basket that was used for a procedure performed on an unknown date.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.This event has been deemed reportable based on the investigation results; thumb ring broken.

• 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
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11386687
• MDR Text Key: 233968473
• Report Number: 3005099803-2021-00672
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1