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

Model Number M00510880

Device Problem Separation Failure (2547)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of (b)(6) 2022.(b)(4).

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during the removal of gallstones procedure.During the procedure, a trapezoid rx was used in an attempt to crush a 1.5cm stone, however, the tip of the basket did not detach from the basket.Another attempt was made with an alliance handle attached to the handle of the trapezoid basket; however, the tip of the basket still did not detach.Finally, by wiggling and moving the basket around the gallstone, the stone came out of the basket.The basket was removed from the patient and the procedure was completed successfully with another trapezoid rx.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during the removal of gallstones procedure.During the procedure, a trapezoid rx was used in an attempt to crush a 1.5cm stone, however, the tip of the basket did not detach from the basket.Another attempt was made with an alliance handle attached to the handle of the trapezoid basket; however, the tip of the basket still did not detach.Finally, by wiggling and moving the basket around the gallstone, the stone came out of the basket.The basket was removed from the patient and the procedure was completed successfully with another trapezoid rx.There were no patient complications reported as a result of this event.

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 reported date of november 18, 2022.Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation observed that the handle cannula was kinked, the sheath was buckled, and the tip still attached to the basket.The reported event was confirmed.Based on all available information, it is possible that the technique used, the tortuosity found during the procedure or the patient's anatomical conditions may have affected the functionality causing a problem to detach the tip.The kinked handle cannula suggests that excess force was applied.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.

• 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: 15960847
• MDR Text Key: 308382695
• Report Number: 3005099803-2022-07132
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0029076678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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