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

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

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 basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to attempt to crush a stone.However, the tip of the basket failed to separate, entrapping the stone inside the basket.Maneuvering the basket was performed to remove the basket from the stone.The basket was disassembled and the wire moved in order to remove the device from the patient.The procedure was completed with another trapezoid rx 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 good.

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 a150301 captures the reportable event of tip failure to separate.Block h10: visual analysis of the returned device found the basket was extended when received and the tip was intact.This confirms the reported event.The handle cannula was found pulled out of the finger ring portion of the handle assembly and lodged inside the working length.The working length was cut to expose and inspect the handle cannula.Both dimples from the screws were visible at proximal section of the handle cannula.The distal screw and proximal screw depth were measured and found within specification.Drag marks were present from dimples towards the proximal end as the cannula had been forcibly pulled out from the set screws.Additionally, the handle cannula and working length were found kinked/bent.A functional test was performed testing the basket tip joint strength through a pull test, and found the tip detached at an acceptable strength.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can result in kinks/bends in the device.This condition would cause friction between the components at the kinked/bent areas leading to an improper distribution of the force applied to the handle through the device and this could have caused issues in releasing the tip.Also, too much force applied to the handle to release the tip can result in handle cannula detachment.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.A labeling review was performed and, from the information available, this device was not used per the instructions for use (ifu) / product label as the device was expired when used.Block h11: correction: b3 date of event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to attempt to crush a stone.However, the tip of the basket failed to separate, entrapping the stone inside the basket.Maneuvering the basket was performed to remove the basket from the stone.The basket was disassembled and the wire moved in order to remove the device from the patient.The procedure was completed with another trapezoid rx 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 good.

• 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: 11316564
• MDR Text Key: 231529084
• Report Number: 3005099803-2021-00356
• 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: 03/10/2021

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: 02/19/2021
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1