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 02/15/2021

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 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 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 in an attempt to crush a stone.However, the tip of the basket failed to separate, entrapping the stone inside the basket.The basket was opened and closed until the stone was released.Additionally, it was observed that after manipulation of the device, the basket would no longer open and close.The device was removed and another trapezoid rx basket 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 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 in an attempt to crush a stone.However, the tip of the basket failed to separate, entrapping the stone inside the basket.The basket was opened and closed until the stone was released.Additionally, it was observed that after manipulation of the device, the basket would no longer open and close.The device was removed and another trapezoid rx basket 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 a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: medical device code a150301 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found the working length (sheath and coil assembly) was kinked/bent in several locations.The sheath was buckled at the proximal section and was detached from the handle.The tip was also found intact and was still attached to the basket-wire assembly.A functional evaluation was performed; the handle was actuated and the basket was able to open and close with the some resistance due to the kinks/bends observed on the device.Therefore, the customer complaint was confirmed.Based on all available information, the investigation concluded that procedural or anatomical factors encountered during the procedure or interaction with additional devices/tools such as the guidewire and scope could have led to a kink in the working length.Kinks on the device would affect the overall performance of the device, thus, making it difficult to open/close the basket and consequently causing issues to separate the tip.Continued attempts to open/close the basket can buckle the sheath, and force applied to the handle in order to open the basket can result in sheath detachment from the handle.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: 11475613
• MDR Text Key: 239618433
• Report Number: 3005099803-2021-00981
• 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: 04/19/2021

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: 09/15/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0026021267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1