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

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the middle common bile duct during a mechanical lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a 1.2cm stone.However, the basket failed to crush the stone.Additionally, the tip failed to separate from the basket to release the stone.They keep swinging the basket until the stone was released.The basket was then removed and another trapezoid basket was used to complete the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the middle common bile duct during a mechanical lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a 1.2cm stone.However, the basket failed to crush the stone.Additionally, the tip failed to separate from the basket to release the stone.They keep swinging the basket until the stone was released.The basket was then removed and another trapezoid basket was used to complete the procedure.There were no patient complications reported 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 h6: device code 2547 captures the reportable event of tip failure to separate.Block h10: visual analysis of the returned device found the working length was kinked in several locations and the sheath was torn in some locations at proximal section.The thumb ring was found detached from the handle and not returned.The handle shows coincident marks that indicate proper assembly during manufacturing process.The handle is damaged where the thumb ring was located indicating likely a lot of force was applied to the device.The tip was still attached to the basket-wire assembly.Therefore the reported issue of "tip failure to separate" is confirmed.Based on all available information, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can kink the working length.This would cause resistance during handle actuation making the force applied to the handle not reach the distal section of the device.Additionally, interaction with the scope could have torn the proximal section of the sheath.It is probable that the thumb ring could have received tensile and/or compressive force(s) 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.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.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the 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: 10431414
• MDR Text Key: 203683973
• Report Number: 3005099803-2020-03422
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• 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: 10/01/2020

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: M00510890
• Device Catalogue Number: 1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1