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

Model Number M00510870

Device Problem Material Deformation (2976)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of side car pushed back.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, it was noticed that the side car was "fringed" at the distal tip.The reported clinical observation may suggest that the side car rx was pushed back.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of side car pushed back.Block h10: investigation results the returned trapezoid rx lithotripter basket was analyzed, and it was observed that the side car rx had remnants of use and was pushed back 2.5 mm, which is out of specification.The reported event was confirmed.The problem could have occurred due to the excessive force applied, the technique used, and/or the patient's anatomical conditions.Based on all available information, adverse event related to procedure was selected as the most probable root cause.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, it was noticed that the side car was "fringed" at the distal tip.The reported clinical observation may suggest that the side car rx was pushed back.There were no patient complications reported 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: 18691499
• MDR Text Key: 336406586
• Report Number: 3005099803-2024-00422
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/28/2024

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 Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0032625848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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