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

Model Number M00510880

Device Problems Difficult to Open or Close (2921); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: imdrf device problem codes a0406 and a040609 capture the reportable investigation result of side car rx push back and handle cannula bent/kinked.Block h10: the returned trapezoid rx retrieval basket was analyzed, and a visual inspection noted that the handle cannula was kinked, and the side car rx was pushed back.A dimensional test was performed and confirmed that the side car rx was pushed back 1.0 mm, which is out of specification.The reported complaint is confirmed.Based on all available information, the handle cannula may have kinked due to excess force applied when using the device's handle.Due to this issue, the basket is unable to open.In addition, the side car-rx was pushed back suggesting extra manipulation due to the technique used or patient's anatomical conditions.Therefore, the most probable root cause for the events found during analysis 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 biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, a trapezoid rx basket was used in an attempt to remove a stone, however the basket failed to open.The nurse attributed the issue to an excess of sludge rather than hard stones, and she had used the basket gently, without applying heavy pressure.There was no stone inside the basket when it failed to open.The procedure was completed with another trapezoid rx.There was no patient complications as a result of this event.Note: this event has been deemed a reportable event based on the investigation results of side car rx push back and handle cannula bent/kinked.Please refer to h10 for investigation details.

• 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: 17934808
• MDR Text Key: 326262258
• Report Number: 3005099803-2023-05359
• 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
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0031597183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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