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 09/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This report pertains to one of two devices used during same procedure.It was reported to boston scientific corporation that two trapezoid rx baskets were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid rx basket in an attempt to crush a 2 cm stone.However, basket failed to crush the stone and the tip failed to separate.A soehendra lithotripter was used but failed.The basket was finally removed from the patient by using a rat tooth forceps to pull the basket wires and released the stone from the basket.Another trapezoid rx basket was used and the same issue occurred.A stent was implanted and patient was scheduled for surgery to remove the stone.There were no patient complications as a result of this event.

Event Description

Note: this report pertains to one of two devices used during same procedure.It was reported to boston scientific corporation that two trapezoid rx baskets were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid rx basket in an attempt to crush a 2 cm stone.However, basket failed to crush the stone and the tip failed to separate.A soehendra lithotripter was used but failed.The basket was finally removed from the patient by using a rat tooth forceps to pull the basket wires and released the stone from the basket.Another trapezoid rx basket was used and the same issue occurred.A stent was implanted and patient was scheduled for surgery to remove the stone.There were no patient complications as a result of this event.Additional information received on october 1, 2022: a plastic stent was implanted to ensure bile drainage until surgery.

Manufacturer Narrative

Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h2: block b5 have been updated based on additional information received october 1, 2022.

• 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: 15549877
• MDR Text Key: 301241358
• Report Number: 3005099803-2022-05801
• 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,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0029686692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/01/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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): Required Intervention
• Patient Sex: Male