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

Model Number	M00535110
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used in the bile duct during an endoscopic bile duct stone removal procedure performed on (b)(6) 2024.During the procedure, the device was used to scrape out the stone after lithotripsy, however, it was observed under fluoroscopy that a metal was protruding vertically from the device.The procedure was completed with another stonetome.No further information has been obtained despite good faith efforts.The reported event may suggest that the cutting wire broke during the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was attempted to be used in the bile duct during an endoscopic bile duct stone removal procedure performed on (b)(6) 2024.During the procedure, the device was used to scrape out the stone after lithotripsy, however, it was observed under fluoroscopy that a metal was protruding vertically from the device.The procedure was completed with another stonetome.No further information has been obtained despite good faith efforts.The reported event may suggest that the cutting wire broke during the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results: the returned stonetome was analyzed, and a visual and microscopic inspection found that the wire anchor was dislodged, and the working length was torn from the distal pierce hole.The cutting wire was not broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was not confirmed.The results of the analysis performed on the returned device found that the working length was torn at the pierce hole.This condition could have been caused by submitting the cutting wire to tension during the handle actuation, in addition with the possibility of the device being energized during the handle actuation, the analyzed problem could happen.Also, bowing the device without being completely out of the scope can lead to tear it and displace or dislodge the cutting wire anchor from its position.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: 20828579
• Report Number: 3005099803-2024-06097
• Device Sequence Number: 3917973
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: 08714729146599
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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 Model Number: M00535110
• Device Catalogue Number: M00535110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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