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

Model Number M00510880

Device Problem Separation Failure (2547)

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

Event Date 12/01/2022

Event Type  malfunction  

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 unknown date.During the procedure, a trapezoid basket was used in an attempt to crush an approximately 1.5 to 2cm stone.However, the tip of the device failed to be detached.The basket was removed from the patient by pulling back on the device, and the stone was removed by wiggling and turning around.The procedure was completed with an extractor pro.There were no patient complications as a result of this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

B3: date of event: 12/01/2022.H10: block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of november 18, 2022.Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h10: the returned trapezoid rx basket was analyzed and a visual inspection observed the tip still attached to the basket.Additionally, the handle cannula was detached, the working length was kinked, the basket was folded, and the side car rx was pushed back.The dimensional test verified that depth of the screws was within the allowed tolerance, and the x-ray performed indicates that the screws were in good condition.The reported event was confirmed.Based on all available information, it is possible that the technique used, the tortuosity found during the procedure or the patient's anatomical conditions may have affected the functionality causing a problem to detach the tip.The detachment of the cannula suggests an excess of applied force.Therefore, the most probable root cause is adverse event related to procedure.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 unknown date.During the procedure, a trapezoid basket was used in an attempt to crush an approximately 1.5 to 2cm stone.However, the tip of the device failed to be detached.The basket was removed from the patient by pulling back on the device, and the stone was removed by wiggling and turning around.The procedure was completed with an extractor pro.There were no patient complications 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: 15963532
• MDR Text Key: 308088874
• Report Number: 3005099803-2022-07232
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/08/2023

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: 11/24/2022
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0028445777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• 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