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

Model Number M00510890

Device Problem Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).(b)(4).The returned trapezoid rx basket was analyzed, and a visual evaluation noted that the working length was kinked, and the side car rx was push backed out of specification.No other issues were noted.The reported event was not confirmed.Based on all available information, the side car rx pushed back and working length kinked is possibly due to the excessive manipulation, possibly caused by the technique used or the anatomical conditions of the patient found at the time of using the device.The instructions for use (ifu) cited: "possible complications include, but may not be limited to: bleeding".There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Therefore, it was concluded that the investigation conclusion code of the event hemorrhage will be documented as known inherent risk of device.Also, during analysis it was found that the working length was kinked, and the side car was pushback.This suggest that the device was subjected to excessive manipulation.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the biliary tract during a removal of biliary calculi procedure performed on (b)(6) 2022.During the procedure, the forceps caused in biliary bleeding.Noradrenaline was given to stop the bleeding.There were no visible damaged or malfunction noted on the device.The procedure was completed with another trapezoid rx.There were no other patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of side car rx push back.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the biliary tract during a removal of biliary calculi procedure performed on may 24, 2022.During the procedure, the forceps caused in biliary bleeding.Noradrenaline was given to stop the bleeding.There were no visible damaged or malfunction noted on the device.The procedure was completed with another trapezoid rx.There were no other patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of side car rx push back.Please see block h10 for full investigation details.

Manufacturer Narrative

Block e1 initial reporter address and city has been updated based on additional information received on august 28, 2022.Block e1: initial reporter facility name: (b)(6).Block h6: device code a0406 captures the reportable investigation results of side car rx push back.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the working length was kinked, and the side car rx was push backed out of specification.No other issues were noted.The reported event was not confirmed.Based on all available information, the side car rx pushed back and working length kinked is possibly due to the excessive manipulation, possibly caused by the technique used or the anatomical conditions of the patient found at the time of using the device.The instructions for use (ifu) cited: "possible complications include, but may not be limited to: bleeding".There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Therefore, it was concluded that the investigation conclusion code of the event hemorrhage will be documented as known inherent risk of device.Also, during analysis it was found that the working length was kinked, and the side car was pushback.This suggest that the device was subjected to excessive manipulation.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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: 15298899
• MDR Text Key: 302838016
• Report Number: 3005099803-2022-04780
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2022
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0027559434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• 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 Age: 36 YR
• Patient Sex: Male
• Patient Weight: 75 KG