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

Model Number M00510880

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

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

Event Date 06/27/2023

Event Type  Injury  

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 (ercp) stone removal procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a 1 cm stone.However, the handle broke and basket was unable to fracture the stone.Moreover, the tip of the basket did not deploy as intended, causing the basket to lodge in the patient's bile duct.A cre balloon was used to dilate the duct and ampulla, allowing the scope with the basket containing the stone to be remove from the bile duct.No patient complications were reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device expiration and manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of handle break.Imdrf device cod a150301 captures the reportable event of tip failure to separate.Imdrf code f2301 captures the event of cre balloon was used to dilate the duct and remove the scope along with the basket containing the stone.

• 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: 17405898
• MDR Text Key: 319858983
• Report Number: 3005099803-2023-03979
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention