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

Model Number M00510880

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of the transparent wire holder on the basket slipped backwards.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket was used in an attempt to remove a stone.The trapezoid was inserted into the cbd and freely passed through it.However, the transparent wire holder on the basket slipping backwards in certain cases.The procedure was completed with another trapezoid basket.There was no patient complication as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of the transparent wire holder on the basket slipped backwards.Block h10: visual inspection of the returned trapezoid rx basket device found that the side car rx was torn and pushed back.A dimensional test confirmed that the side car rx was pushed back 7.0 mm, which is out of specification.No other issues were noted.The reported complaint is confirmed.Based on all available information, it is possible that factors such as manipulation, technique used, or the patient's anatomical conditions may have contributed to this event.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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket was used in an attempt to remove a stone.The trapezoid was inserted into the cbd and freely passed through it.However, the transparent wire holder on the basket slipping backwards in certain cases.The procedure was completed with another trapezoid basket.There was no patient complication 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17371726
• MDR Text Key: 319558408
• Report Number: 3005099803-2023-03871
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• 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: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1