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

Model Number M00510880

Device Problems Use of Device Problem (1670); Separation Failure (2547)

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

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a23 captures the reportable event of basket failure to crush stone.Imdrf device code a150301 captures the reportable event of tip failure to separate.Impact code f19 captures the reportable event of patient had to be sent to surgery.Impact code f08 captures the reportable event of hospitalization.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography with stone removal procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a large stone that could not be removed with traditional balloon sweep.However, the captured stone could not be crushed.An alliance handle was attached for mechanical lithotripsy, however, upon closing the handle, the tip failed to disengage, and the stone would not break.The process was repeated several times with the alliance handle; still the tip would not disengage.The patient had to be sent to surgery the same day, to remove the basket and the stone.The patient was admitted in the hospital beyond the standard of care.

• 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: 16982782
• MDR Text Key: 315738234
• Report Number: 3005099803-2023-02611
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0030058245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female