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

Model Number M00510890

Device Problems Break (1069); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

(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 basket was used during a lithotripsy procedure performed on (b)(6) 2019.According to the complainant, prior to the procedure, the trapezoid basket was inspected and was found to open and close without issues.During the procedure, an alliance ii was used in conjunction with the trapezoid rx basket in an attempt to crush a stone.Reportedly, the stone was hard and could not be crushed.The physician squeezed the handle to its limit in an attempt to detach the tip of the basket; however, the thumb ring broke and the tip failed to separate.Endoscopic papillary large balloon dilation (eplbd) was performed in advance and the stone was able to be pulled out into the duodenum without being crushed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Device code 1069 captures the reportable event of thumb ring break.Device code 2547 captures the reportable event of tip failure to separate.Visual inspection of the device found the thumb ring was damaged and detached from the handle.However, the handle has coincident marks that indicate proper assembly during manufacturing.The handle is damaged where the thumb ring was located likely due to excessive force applied to the device.The tip is intact and still attached to the basket assembly.The basket tip joint strength was measured and found to be within specification.The report that the tip failed to separate was not confirmed; measurements of the basket tip joint strength confirmed release of the basket tip occurred at forces within specifications.Based on all available information, the investigation concluded that procedural or anatomical factors encountered during the procedure likely affected the device performance and integrity.Patient anatomy and user maneuvering to reach the intended locations can cause resistance during handle actuation to open/close the basket.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.Additionally, 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 review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a lithotripsy procedure performed on (b)(6) 2019.According to the complainant, prior to the procedure, the trapezoid basket was inspected and was found to open and close without issues.During the procedure, an alliance ii was used in conjunction with the trapezoid rx basket in an attempt to crush a stone.Reportedly, the stone was hard and could not be crushed.The physician squeezed the handle to its limit in an attempt to detach the tip of the basket; however, the thumb ring broke and the tip failed to separate.Endoscopic papillary large balloon dilation (eplbd) was performed in advance and the stone was able to be pulled out into the duodenum without being crushed.There were no patient complications reported 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: 9078827
• MDR Text Key: 159127406
• Report Number: 3005099803-2019-04598
• 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: 12/09/2019

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 Expiration Date: 08/23/2019
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0022554278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1