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

Model Number M00510870

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a mechanical lithotripsy procedure performed on (b)(6) 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a stone and detach the tip.However, the basket tip failed to detach, and handle separated from the trapezoid snare.Wide cut+ was done to prevent the snare from coming out.The physician had to find other techniques and use a different device.The patient had a bleeding during the removal of the snare.There was an increased procedural time and prolonged sedation of the patient.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a mechanical lithotripsy procedure performed on (b)(6) 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a stone and detach the tip.However, the basket tip failed to detach, and handle separated from the trapezoid snare.Wide cut+ was done to prevent the snare from coming out.The physician had to find other techniques and use a different device.The patient had a bleeding during the removal of the snare.There was an increased procedural time and prolonged sedation of the patient.

Manufacturer Narrative

Block h6: device code a150301 captures the reportable event of tip failure to separate.Device code a0501 captures the reportable event of handle detachment of device or device component.Patient code e0506 captures the reportable issue of hemorrhage, major.Impact code f2202 captures the reportable event of endoscopic procedure.Block h10: the returned trapezoid rx retrieval basket was analyzed, and a visual inspection noted that the handle cannula was detached, which under microscope magnification noted drag marks of the fastening screws.An x-ray showed that the screws were in good condition, and a dimensional test verified that the depth of the screws were within the allowed tolerance.It also found that the retrieval basket side car rx was pushed back approximately 6.0 mm, which is out of specification.The observed side car rx push back was likely caused by manipulation of the device during use; possibly during attempts to remove the device after the handle cannula broke.Additionally, it was observed the internal wires were bent and outside of the device, the internal sheath was detached, and the tip was confirmed still attached to the basket.The reported event was confirmed.Based on all available information, it is possible that an over manipulation of the device; the technique used, the tortuosity found during the procedure or the patient's anatomical conditions could have contributed to the event.Therefore, the most probable root cause for the investigation findings is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: 15974433
• MDR Text Key: 307883469
• Report Number: 3005099803-2022-07409
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0029855005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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: Female