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 01/09/2023

Event Type  Injury  

Manufacturer Narrative

Device code a150301 captures the reportable event of tip failure to separate.A photo submitted by the customer showed that the wires were detached from the tip.Therefore, the reported complaint is confirmed.During the media analysis, it was discovered that the wires had become detached from the device's tip.However, according to the event description, a soelhendra was used to break the tip of the device and release it.Because the tip was purposefully separated from the basket's wires, this is not considered a failure.This, however, suggests that the tip did not separate and that the physician was forced to use another device to complete the procedure.As a result, the reported complaint will be confirmed using the code of tip releasing failed as analyzed.Furthermore, without a proper evaluation of the device, the most likely cause that contributed to the events remains unknown.Because the findings of the investigation do not lead to a clear conclusion about the cause of the reported adverse events, cause not established is chosen as the most likely cause for the complaint.

Event Description

It was reported that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a 3 cm stone.However, basket failed to crush the stone.Furthermore, the tip failed to separate from the basket in order to release the stone.A sohendra was used to remove the basket by breaking the pullwire and separating the basket tip.A spyglass was then utilized to drill through the stone.The detached tip was extracted with an extractor pro retrieval balloon, and the procedure was completed with another trapezoid basket.There were no patient complications reported as a result of this event.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16301344
• MDR Text Key: 308822804
• Report Number: 3005099803-2023-00263
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029500961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention