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

Model Number M00510880

Device Problems Separation Failure (2547); Difficult to Open or Close (2921)

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

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of another device was used to rescue the situation.

Event Description

It was reported to boston scientific corporation 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, a trapezoid rx basket was used in an attempt to crush a stone, however, upon trying to crush the stone, the device failed to break, and the handle failed to open again to release the stone.Another device was used to rescue the situation.The procedure was completed with a different device.There were no patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block d4 (lot number and expiration date) and h4 has been updated based on additional information received on june 15, 2023.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf impact code f2301 captures the reportable event of another device was used to rescue the situation.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection noted that the handle cannula was detached and was not returned.The working length was detached in two parts.The thumb ring shows stress marks.The proximal section of the sheath was torn.The pull wire was separated from the working length, kinked, and detached from the cannula.The tip of the basket was detached and not returned.The distal and proximal screw depth were measured and found within specification.The basket was returned without the tip, suggesting that it could be released as expected.Therefore, the reported event of tip failure to separate and basket failure to release stone was not confirmed.However, the device was returned with multiple damages.Based on all available information, it is most likely that procedural factors and handling of the device affected its performance.The stress marks on the thumb ring are evidence of over manipulation.It is possible that due to the size of the stone while attempting to crush it could have led to the marks on the thumb ring and the damaged to the sheath.Additional force applied to the device could have ended detaching the handle cannula and the pull wire, and as consequence kinking it.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during procedure and the device had no influence on event.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a stone, however, upon trying to crush the stone, the device failed to break, and the handle failed to open again to release the stone.Another device was used to rescue the situation.The procedure was completed with a different device.There were no patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 16959588
• MDR Text Key: 315530958
• Report Number: 3005099803-2023-02596
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0029422767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention