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

Model Number M00510870

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 08/29/2023

Event Type  Injury  

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 changiopancreatography (ercp) with stone extraction procedure performed on august 29, 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a 1.5cm stone; however, the stone was too large to crush.An alliance lithotripsy handle and a soehendra lithotripsy handle were used to crush the stone or detach the tip but were unsuccessful.The handle and handle cannula of the lithotripter basket broke leaving the basket firmly lodged around the stone.The physician used a spy glass with a holmium laser to break the stone free from the basket and remove the basket from the patient.It was reported that there was swelling in the common bile duct.The patient was reported to have fully recovered.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of handle break and handle cannula break.Imdrf impact code a0401 captures the spy glass with a holmium laser used to break the stone free from the basket and remove the basket from the patient.

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) with stone extraction procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a 1.5cm stone; however, the stone was too large to crush.An alliance lithotripsy handle and a soehendra lithotripsy handle were used to crush the stone or detach the tip but were unsuccessful.The handle and handle cannula of the lithotripter basket broke leaving the basket firmly lodged around the stone.The physician used a spy glass with a holmium laser to break the stone free from the basket and remove the basket from the patient.It was reported that there was swelling in the common bile duct.The patient was reported to have fully recovered.

Manufacturer Narrative

H2: correction block h10 impact code has been corrected to f2301.Block h6: imdrf device code a0401 captures the reportable event of handle break and handle cannula break.Imdrf impact code f2301 captures the spy glass with a holmium laser used to break the stone free from the basket and remove the basket from the patient.Block h10: investigation results: the returned trapezoid rx device was received for analysis.A visual inspection found that the internal wire including the basket was returned; however, the rest of the device was not returned.The internal wire was inspected and found to be bent.Additionally, microscopic inspection showed signs of the internal wire being cut.The device was likely cut to remove the device due to the complications encountered during the procedure.Based on the information available, the reported event could not be confirmed as the handle of the device was not returned.It is possible that manipulation, technique used, or the patient's anatomical conditions could have contributed to this event; however, without analysis of the device the root cause cannot be established.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of handle break and handle cannula break.Imdrf impact code a0401 captures the spy glass with a holmium laser used to break the stone free from the basket and remove the basket from the patient.Block h10: investigation results: the returned trapezoid rx device was received for analysis.A visual inspection found that the internal wire including the basket was returned; however, the rest of the device was not returned.The internal wire was inspected and found to be bent.Additionally, microscopic inspection showed signs of the internal wire being cut.The device was likely cut to remove the device due to the complications encountered during the procedure.Based on the information available, the reported event could not be confirmed as the handle of the device was not returned.It is possible that manipulation, technique used, or the patient's anatomical conditions could have contributed to this event; however, without analysis of the device the root cause cannot be established.

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) with stone extraction procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a 1.5cm stone; however, the stone was too large to crush.An alliance lithotripsy handle and a soehendra lithotripsy handle were used to crush the stone or detach the tip but were unsuccessful.The handle and handle cannula of the lithotripter basket broke leaving the basket firmly lodged around the stone.The physician used a spy glass with a holmium laser to break the stone free from the basket and remove the basket from the patient.It was reported that there was swelling in the common bile duct.The patient was reported to have fully recovered.

• 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: 17801277
• MDR Text Key: 324111701
• Report Number: 3005099803-2023-04984
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• 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,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0032061715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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
• Patient Sex: Female