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

Model Number M00510890

Device Problems Break (1069); Use of Device Problem (1670); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Device code a150301 captures the reportable event of tip failure to separate.Device code a23 captures the reportable event of basket failure to crush stone.Device code a0401 captures the reportable event of thumb ring damage.Impact code f1901 captures the reportable event of additional surgery.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during a cholangioscopic lithotripsy procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket was used in conjunction with an alliance handle in an attempt to crush the stone; however, the stone could not be crushed.When the basket was opened, the stone was caught in the basket wire and was incarcerated.Additionally, the thumb ring was damaged in the process.An attempt was made to release the incarcerated stone using an olympus rescue handle; however, it could not be released and the tip of basket fail to separate.It was reported that a patient injury occurred, and an additional surgery procedure was performed to solve the issue.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code a150301 captures the reportable event of tip failure to separate.Device code a23 captures the reportable event of basket failure to crush stone.Device code a0401 captures the reportable event of thumb ring damage.Impact code f1901 captures the reportable event of additional surgery.Block h10: the returned trapezoid rx basket was analyzed, and it was observed that the thumb ring was detached and has traces of junction with the handle.Additionally, the sheath was detached, the working length was kinked, and the pull wire was returned out of the device (detached), was incomplete, and kinked.The device was returned without the basket and the tip.The reported event was confirmed.Based on all available information, it is possible that during the procedure, an excess force or a certain inclination was applied, which induced an excess of stress on the thumb ring causing its detachment from the handle; perhaps the technique used, or patient's anatomical conditions could have contributed to this event.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Also handling or manipulation of the device during its use could have kinked the working length and pull wire, finally, causing the detachment of the pull wire.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.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during a cholangioscopic lithotripsy procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket was used in conjunction with an alliance handle in an attempt to crush the stone; however, the stone could not be crushed.When the basket was opened, the stone was caught in the basket wire and was incarcerated.Additionally, the thumb ring was damaged in the process.An attempt was made to release the incarcerated stone using an olympus rescue handle; however, it could not be released and the tip of basket fail to separate.It was reported that a patient injury occurred, and an additional surgery procedure was performed to solve the issue.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 16507365
• MDR Text Key: 310949716
• Report Number: 3005099803-2023-01156
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/21/2023

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: 09/26/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0030216395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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