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

Model Number	M00535130
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic papillotomy procedure performed on (b)(6) 2023.During the procedure outside the patient, when the mandrel was attempted to be removed from the stonetome, only the tip came off and the sheath 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of molding tip of the curving mandrel was detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event 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, and it was not returned, which was consistent with the findings when the device was observed under magnification.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 reported event of detached molding tip of the curving mandrel was confirmed.Upon analysis, it was found that the molding tip was detached from the curving mandrel.Based on the condition of the device, the problem found could have been generated due to handling to remove 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.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic papillotomy procedure performed on (b)(6) 2023.During the procedure outside the patient, when the mandrel was attempted to be removed from the stonetome, only the tip came off and the sheath 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.

• 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: 17164813
• Report Number: 3005099803-2023-03257
• Device Sequence Number: 5744366
• Product Code: LQR
• UDI-Device Identifier: 08714729146575
• UDI-Public: 08714729146575
• 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,Followup
• 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: 10/25/2024
• Device Model Number: M00535130
• Device Catalogue Number: 3513
• Device Lot Number: 0030426245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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