MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY

Model Number	M00535150
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was intended to be used in the bile duct during a biliary stone removal procedure performed on (b)(6) 2023.During the preparation outside the patient, an attempt was made to remove the stylet from the tip of the stonetome; however, the tip of the stylet bent and could not be removed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: the molding tip was detached from the curving mandrel.Please refer to block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of molding tip of the curving mandrel was detached.Block h10: the returned stonetome was analyzed, and a visual evaluation noted that the molding tip was detached from the curving mandrel, which was consistent with the findings when the device was observed under magnification.The molding tip was not returned.Per the dimensional inspection, the thickness and the length of the coined end of the forming mandrel were measured, and both were within specification.No other problems with the device were noted.The product analysis revealed that the molding tip was detached from the curving mandrel.This condition could have been generated due to handling upon the removal of the mandrel from the device, such as if the physician rotated the molding tip instead of pulling the mandrel.Based on all gathered information, the most probable root cause is adverse event related to procedure.

• Brand Name: STONETOME
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17383263
• Report Number: 3005099803-2023-03957
• Device Sequence Number: 6210938
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: 08714729146667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2024
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0029400977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown