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

Model Number M00510890

Device Problems Break (1069); Separation Failure (2547)

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

Event Date 10/16/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during a choledocholithiasis lithotripsy procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was used in an attempt to crush a 0.7cm stone.The basket could not be closed due to a handle malfunction, and it became embedded in the common bile duct and could not be withdrawn.The stone fell out of the basket as the physician continued to shake it.The basket was withdrawn with effort after several operations, and a new trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Initial reporter phone: (b)(6).Device code a0401 captures the reportable event of due to the fault of the handle, the basket could not be closed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during a choledocholithiasis lithotripsy procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was used in an attempt to crush a 0.7cm stone.The basket could not be closed due to a handle malfunction, and it became embedded in the common bile duct and could not be withdrawn.The stone fell out of the basket as the physician continued to shake it.The basket was withdrawn with effort after several operations, and a new trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.*additional information received on february 16, 2023.The sheath/heat shrink was partially damaged.They were unable to crush the stone and the tip failed to separate.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h2: additional information received on february 16, 2022.See b5 for details.Correction to content previously reported in h6 device codes.

• 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: 16381060
• MDR Text Key: 309603228
• Report Number: 3005099803-2023-00548
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/09/2023

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 Expiration Date: 02/25/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0028941628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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 Age: 98 YR
• Patient Sex: Female