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 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(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 biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the stone could not be crushed and the tip of the basket failed to separate, leaving the stone stuck inside the basket.The basket was moved and attempts were made to open and close the basket until the stone was finally released.The basket was then removed from the patient and a different device was used to complete the procedure.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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the stone could not be crushed and the tip of the basket failed to separate, leaving the stone stuck inside the basket.The basket was moved and attempts were made to open and close the basket until the stone was finally released.The basket was then removed from the patient and a different device was used to complete the procedure.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 h6: problem code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found that the tip was attached to the basket when it was received.Therefore, the reported complaint is confirmed.The working length was kinked in several locations.The sidecar rx tunnel was found torn and pushed back 5mm which is out of specification.The sheath was torn/ buckled in some locations at the proximal section.The thumb ring was detached from the handle.The handle cannula was also detached and it was found inside of the working length indicating that an excessive force was applied to the device.The distal screw and proximal screw depth were measured and both were found within specification.Based on all available information, the investigation concluded that procedural and 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 lead to the handle cannula pulling out from the finger ring and kinks in the working length.Interaction with other devices could have also contributed the torn at the proximal section of the sheath.The interaction with the guidewire could have contributed to the torn and pushed back side car rx tunnel.The encountered failure is consistent with one caused when the guidewire is pulled through the sidecar tunnel while it is placed in the tunnel.Drag marks were observed indicating that a lot of force was applied to the handle to crush the stone or retract the basket.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: 10563932
• MDR Text Key: 207906547
• Report Number: 3005099803-2020-03954
• 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: 10/27/2020

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: 09/15/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR