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

Model Number M00510860

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received for analysis, 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 distal coledoco during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid rx basket was used to remove multiple stones.The stone sizes ranged from 1 to 1.5 cm.However, when an alliance handle was used in conjunction with the trapezoid basket, the basket failed to crush a stone.Additionally, the tip failed to separate from the basket to release the stone.Eventually, the stone was released by moving and washing through the basket.The basket was removed from the patient by cutting the catheter and manually moving the basket wires.The procedure was completed with a non-bsc device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.

Event Description

It was reported that a trapezoid rx lithotripter basket was used in the distal coledoco during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid rx basket was used to remove multiple stones.The stone sizes ranged from 1 to 1.5 cm.However, when an alliance handle was used in conjunction with the trapezoid basket, the basket failed to crush a stone.Additionally, the tip failed to separate from the basket to release the stone.Eventually, the stone was released by moving and washing through the basket.The basket was removed from the patient by cutting the catheter and manually moving the basket wires.The procedure was completed with a non-bsc device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.

Manufacturer Narrative

Block h6: device code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection found the returned device was received with the basket retracted and the tip still attached.The side car rx tunnel was found pushed back 6 mm, which is out of specification, and torn.The working length was found kinked, stretched, and was cut from the handle.The sheath was broken and torn.The handle cannula was found detached from the handle.The distal screw and proximal screw depth were measured and found within specification.Based on all available information, it is likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and integrity.Handling and manipulation of the device during its use could lead to the handle cannula detaching from the handle.Drag marks observed indicate that force was applied to the handle when retracting the basket.This excessive force may have caused the kinks in the working length and stretched condition.Marks observed in the side car rx tunnel are consistent with the ones caused when the guidewire is pulled out through the side car wall once the guidewire is in place.Therefore, the most probable root cause is adverse event related to the 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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 10474499
• MDR Text Key: 209427263
• Report Number: 3005099803-2020-03563
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• 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: 10/12/2020

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: 03/03/2021
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 0025297401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1