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

Model Number M00510880

Device Problem Separation Failure (2547)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a stone extraction procedure performed on an unknown date.An alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the basket failed to crush the stone.Additionally, the tip failed to separate from the basket to release the stone.A sohendra lithotripter was used and succeeded in removing the basket, but failed in separating the tip.The stone was left in the patient and a plastic stent was placed to drain the common bile duct.There were no patient complications as a result of this event.The patient is reportedly doing well.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found the basket was extended and the tip was intact.The working length returned separated from the handle assembly.The handle cannula was found pulled out of the finger ring portion of the handle assembly.The handle cannula showed that it was cut and the cut part was not returned.The working length was kinked and the coil assembly was unraveled.Device was inspected under magnification and found evidence that indicates a mechanical tool was used to cut the device.The distal and proximal screw depth were measured and found within specifications.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and integrity.Handling and manipulation of the device during the procedure can result in device kink.This condition would cause friction between the components at kinked areas leading to an improper distribution of the force applied to the handle through the device and could have caused issues to release the tip.Also, too much force applied to the handle to release the tip can result in handle cannula detachment.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 lithotripter basket was used in the common bile duct during a stone extraction procedure performed on an unknown date.An alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the basket failed to crush the stone.Additionally, the tip failed to separate from the basket to release the stone.A sohendra lithotripter was used and succeeded in removing the basket, but failed in separating the tip.The stone was left in the patient and a plastic stent was placed to drain the common bile duct.There were no patient complications as a result of this event.The patient is reportedly doing well.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11476166
• MDR Text Key: 239797322
• Report Number: 3005099803-2021-00986
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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: 10/19/2021
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0026211410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1