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

Model Number M00510880

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a large stone was attempted to be removed.However, the stone could not pass through the papilla.The basket was then attached to an alliance handle and attempted to crush the stone but failed.Additionally, the tip of the basket would not separate to release the stone.The handle part of the device was cut and the sheath was removed from the endoscope.The stone was finally crushed using a non-bsc lithotripter device, and the procedure was completed.There were no patient complications as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter city: (b)(6).Block h6: device code 2547 captures the reportable event of tip failure to separate.Block h10: visual analysis found the returned device was cut in different sections ( pull wire, pull wire sheath, coil assembly).The pull wire was observed kinked in several sections.Also, the thumb ring was found detached from the handle, however the handle has coincident marks that indicate proper assembly during the manufacturing process.The basket wires were found to be deformed, and the tip was intact and still attached to the basket wires assembly.Since the issue occurred during the procedure, it is most likely that procedural or anatomical factors encountered could have affected the device performance and integrity.Handling and manipulation of the device can lead to deform/bent basket wires.Also, interaction with another device could have contributed to the basket deformed/bent.Additionally, during use of the device, the thumb ring could have received tensile and/or compressive force applied parallel to the length of the device.Detachment of the thumb ring from the handle assembly can occur when force is applied perpendicular to the thumb ring/handle assembly, forcing the thumb ring out of the handle assembly.The damages observed in the section of the handle where the thumb ring was located indicates that the device was submitted to tension forces during the use of the device.During manufacturing, the handle is operated and it is confirmed that the basket deploys and retracts.This inspection would have detected the encountered damage; however, there is no control how the devices and handled/manipulated in the field.Therefore, the investigation conclusion code for the issue of tip failure to separate, basket deformed/bent, the thumb ring detached, and the pull wire kinked will be documented as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A manufacturing batch record 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 device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a large stone was attempted to be removed.However, the stone could not pass through the papilla.The basket was then attached to an alliance handle and attempted to crush the stone but failed.Additionally, the tip of the basket would not separate to release the stone.The handle part of the device was cut and the sheath was removed from the endoscope.The stone was finally crushed using a non-bsc lithotripter device, and the procedure was completed.There were no patient complications 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
• MDR Report Key: 8793046
• MDR Text Key: 151119150
• Report Number: 3005099803-2019-03598
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1