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

Model Number M00510870

Device Problem Separation Failure (2547)

Patient Problems Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct and papilla during an endoscopic retrograde cholangiopancreatography (ercp procedure performed on an unknown date.During the procedure, a trapezoid rx basket in conjunction with an alliance handle was used in an attempt to remove a stone in the common bile duct.However, the tip of trapezoid rx basket did not disengage after multiple attempts of opening or closing freehandedly or with the alliance handle.The wire near the trapezoid basket handle was cut to pull scope out and free up the working channel.An attempt was made with the use of forceps, snares and rat tooth to pull the basket out of the papilla, however, it was not successful.The physician decided to end the case and placed the wire of the trapezoid into the stomach, so it was out of the esophagus and to bring patient back the next day for a second ercp.Ehl via spyglass on the stone was performed the next day and had successfully freed up and removed the trapezoid basket out of the common bile duct and papilla, and completely removed from the gi tract.The patient was not doing well and experienced discomfort or pain prior to the second ercp.However, after the ehl via spyglass procedure, patient was expected to fully recover.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

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 (b)(6) 2023.H6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf patient code e2008 captures the reportable event of retained basket and catheter wire in the patient.Imdrf patient code e2311 captures the reportable patient experience of discomfort.Imdrf patient code e2330 captures the reportable patient experience of pain.Imdrf impact code f05 captures the reportable event of delay to treatment, where patient had to come back for a second ercp the next day.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2202 captures the reportable event of the need for a second ercp the following day.

• 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: 17010644
• MDR Text Key: 316020015
• Report Number: 3005099803-2023-02721
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2023
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0030001766
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization