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

Model Number M00510890

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/26/2022

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) procedure performed on (b)(6) 2022.During the procedure, a trapezoid basket was used in an attempt to crush a 3 cm stone.However, the handle broke leaving the stone stuck inside the basket, and the basket stuck inside the patient.Wire cutters were used to cut the handle off to remove the scope from the patient.A duodenoscope was used and spyglass with ehl was performed to break the stone inside the basket, freeing the basket from the bile duct.Bleeding did occur, but the physician was not sure of the source.The patient was kept overnight and was discharged the following day on (b)(6) 2022.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, a trapezoid basket was used in an attempt to crush a 3 cm stone.However, the handle broke leaving the stone stuck inside the basket, and the basket stuck inside the patient.Wire cutters were used to cut the handle off to remove the scope from the patient.A duodenoscope was used and spyglass with ehl was performed to break the stone inside the basket, freeing the basket from the bile duct.Bleeding did occur, but the physician was not sure of the source.The patient was kept overnight and was discharged the following day on (b)(6) 2022.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of handle break.Block h10: the trapezoid rx basket was analyzed, and a visual inspection noted that the handle cannula had become detached and had not been returned.The sheath was cut off from the handle and never returned, and the working length was kinked.The screws' tip has been pushed inward, but the basket's tip remains attached.Dimensional inspection noted that the length of the screws is less than the minimum tolerance.The reported event was confirmed because the results of the analysis performed on the returned device showed that the handle cannula was detached.Based on the information available, it is possible that the manipulation or technique used to interact with the device at the time resulted in the working length being kinked and the sheath being detached.Furthermore, the screw length was less than the acceptable minimum, and the tip of the screws were pushed inward.It was determined that the most likely cause is attributable to the screw supplier.The proper fastening is not provided due to the condition of the screws (even if the screws had the appropriate depth), so the force applied when activating the device causes the handle cannula to detach.Therefore, the most probable root cause of the issue handle cannula detached is "manufacturing deficiency"; an investigation is underway to address this problem with the supplier.The most probable root cause of the investigation finding of working length kinked and the sheath being detached is "adverse event related to procedure".Lastly, the reported patient code "hemorrhage, minor" was assigned as "known inherent risk of device", because it is known and documented in the labeling.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / 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: 15642759
• MDR Text Key: 302163541
• Report Number: 3005099803-2022-06195
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• 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: 12/14/2022

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: 12/16/2022
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0028569282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention