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

Model Number M00510870

Device Problems Break (1069); Use of Device Problem (1670); Separation Failure (2547)

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

Event Date 09/18/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a23 captures the reportable event of basket failure to crush stone.Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a0401 captures the reportable event of pull wire break.Imdrf impact code f19 captures the emergency surgery required to remove the basket and stone 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) procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used to retrieve a 5 mm stone from the common bile duct.Upon cannulation, the bile duct was observed to be narrow and long, ranging to be 2-3 mm in diameter.As the basket retrieved the stone, the basket was unable to pass through the narrow duct since the stone size was larger than the common bile duct.Attempts to jiggle the basket to dislodge the stone were unsuccessful.The handle of the trapezoid was cut, and a soehendra lithotripter was connected to the basket wire.However, subsequent tightening of the wire did not break the stone or separate the basket tip.Instead, the nurse heard the wire snapping off.The patient was sent to emergency surgery where the basket and stone were removed from the patient.There were no patient complications as a result of this event.The patient is reported to be well after the surgery.

Manufacturer Narrative

Block h6: imdrf device code a23 captures the reportable event of basket failure to crush stone.Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a0401 captures the reportable event of pull wire break.Imdrf impact code f19 captures the emergency surgery required to remove the basket and stone from the patient.Block h10: the returned trapezoid rx was analyzed, and a visual inspection observed that the device is completely destroyed.The working length was detached from the handle.Additionally, the working length was found torn apart on various sides.The basket was not returned for analysis.Dimensional inspection observed the side car - rx was pushed back approximately 5 mm.The reported event was confirmed.Based on all available information, it is possible that the side car - rx was already pushed back during the attempt to crush the stone or dislodge the tip of the basket.As a result, the working length have extra pressure making the basket unable to open/close.The user took the decision to follow the emergency procedure stated on the emergency precautions side in the instructions for use (ifu).Therefore, the most probable cause is adverse event related to procedure.In addition, surgical intervention was identified as a "known inherent risk of device" since the instructions for use indicates to follow clinical and/or surgical standards of practice in case a calculus can't be removed.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 (b)(6) 2023.During the procedure, a trapezoid rx basket was used to retrieve a 5 mm stone from the common bile duct.Upon cannulation, the bile duct was observed to be narrow and long, ranging to be 2-3 mm in diameter.As the basket retrieved the stone, the basket was unable to pass through the narrow duct since the stone size was larger than the common bile duct.Attempts to jiggle the basket to dislodge the stone were unsuccessful.The handle of the trapezoid was cut, and a soehendra lithotripter was connected to the basket wire.However, subsequent tightening of the wire did not break the stone or separate the basket tip.Instead, the nurse heard the wire snapping off.The patient was sent to emergency surgery where the basket and stone were removed from the patient.There were no patient complications as a result of this event.The patient is reported to be well after the surgery.

• 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: 17894948
• MDR Text Key: 325240137
• Report Number: 3005099803-2023-05386
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0030976326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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