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 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and 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 biliary tree during a lithohtripsy 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 stone.However, the basket failed to crush the stone and the tip failed to separate to release the stone.The basket was opened and closed until the stone was released.The procedure was completed with another trapezoid basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the biliary tree during a lithohtripsy 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 stone.However, the basket failed to crush the stone and the tip failed to separate to release the stone.The basket was opened and closed until the stone was released.The procedure was completed with another trapezoid basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block a2: patient"s exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: device code 2547 captures the reportable event of tip failure to separate.Block h10: visual analysis of the returned device found that the basket wires were bent/kinked.The working length (sheath and coil assembly) was kinked approximately at 5.5cm from distal end.The tip was still attached to the basket-wire assembly.Therefore,the reported issue of "tip failure to separate" is confirmed.Functional inspection found the basket was able to open and close with some resistance due to the kink observed at distail section of working length.A pull test was performed to the basket tip joint and the tip detached from the basket at 27.0941lbf which is within acceptable specification.The handle assembly was checked under x-ray and it was observed that the handle cannula is properly attached to the finger ring.Based on all available information, it is most likely that procedural or anatomical factors encountered during procedure could have kinked the device and basket wires, attempts to crush the stone could have kink the basket wires, interaction with the scope or the interacting with other devices such the guide wire could have kinked the working length.Kinks on the device would affect the overall performance of the device making difficult to open/close the basket and consequently causing issues to separate the tip.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.

• 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: 10672964
• MDR Text Key: 221558261
• Report Number: 3005099803-2020-04553
• 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: 12/01/2020

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 Expiration Date: 10/15/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024604617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1