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

Model Number M00510890

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the 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 in an attempt to crush a 15mm stone.However, the device got stuck and would not close or crush the stone.Spyglass was used in order to go inside and see what was happening.A laser was used to break the stone and complete the procedure.The basket was removed from the patient in the open position.An image of the device provided by the customer showed the handle cannula was broken.The patient's condition at the conclusion of the procedure was reported to be stable with pain.

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of handle cannula break.Block h10: the returned trapezoid rx was analyzed, and a visual inspection noted that only the internal wires (including) the basket was returned.The internal wire was observed cut.The photos provided by the customer confirmed the handle cannula detached and the basket with the tip inside of the patient.Additionally, the procedure was performed on 4/18/2022 and the expiration date of the device is 9/15/2021; therefore, the device shelf life exceeded.The reported event was confirmed.Based on all available information, it is possible that due to the manipulation or technique used at the time to interact with the device in conjunction with the tortuousness of patient's anatomy, and the force applied could have affected the functionality of the device resulting in the detachment of the handle cannula.Since the handle and the handle cannula was not return, it is not possible to carry out a more thorough investigation to determine the influence of the device.The internal wire was returned cut, it is possible that the internal wire was cut at the time of removing the device.Therefore, the most probable root cause 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.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on april 18, 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid rx in an attempt to crush a 15mm stone.However, the device got stuck and would not close or crush the stone.Spyglass was used in order to go inside and see what was happening.A laser was used to break the stone and complete the procedure.The basket was removed from the patient in the open position.An image of the device provided by the customer showed the handle cannula was broken.The patient's condition at the conclusion of the procedure was reported to be stable with pain.

• 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: 14403247
• MDR Text Key: 291953290
• Report Number: 3005099803-2022-02619
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0026021267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/14/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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