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

Model Number M00510880

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of pull wire break.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the trapezoid rx was opened and closed before inserting in the working channel.However, when the device was inserted and opened inside the patient, the pull wire broke.Another trapezoid rx basket was used to complete the procedure.No patient complications were reported as a result of the event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the trapezoid rx was opened and closed before inserting in the working channel.However, when the device was inserted and opened inside the patient, the pull wire broke.Another trapezoid rx basket was used to complete the procedure.No patient complications were reported as a result of the event.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection observed that no issues with the pull wire were identified.Additionally, it was noted that the handle cannula was broken.The reported event of pull wire break was not confirmed.Based on all available information, the break in the handle cannula could have been generated due to an excess of force when using the handle, manipulation of the device or the technique used.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 17419671
• MDR Text Key: 320291883
• Report Number: 3005099803-2023-04088
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0029968443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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 Sex: Female