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

Model Number M00510880

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was to be used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the basket tip fractured before it was used in the patient.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a050103 captures the reportable event of basket tip fractured before use / premature deployment.

Manufacturer Narrative

Block h6: imdrf device code a050103 captures the reportable event of basket tip fractured before use / premature deployment.Block h10: the returned trapezoid rx was analyzed, and a visual inspection observed that the that the basket tip was detached.However, there is no way to confirm that this occurred prematurely.The reported event was not confirmed.Based on all available information, it is possible that the device faced some resistance that caused the reported event.Perhaps the manipulation or technique used could have contributed to the basket tip detaching prematurely.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 to be used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6)2023.During the procedure, the basket tip fractured before it was used in the patient.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 17673282
• MDR Text Key: 322540209
• Report Number: 3005099803-2023-04627
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0031297553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG