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

Model Number	M00535150
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned stonetome was analyzed, and a visual evaluation noted that the distal tip was returned in a bowed position and, the cutting wire was broken and kinked at the handle section.It is possible the device was bowed when the physician actuated the handle and then the cutting wire broke in the handle.An x-ray inspection was performed, and the images revealed that the working length was kinked in the hypo-tube transition.The bowing function could not be performed due to the device condition (broken cutting wire).No other problems with the device were noted.The product analysis revealed that the cutting wire was broken and bent at the handle section and the working length was bent.These conditions could have been generated due to handling and manipulation of the device during its use.It is likely that the kink in the working length at the proximal section could have caused some internal tension forces on the cutting wire during the handle actuation.This condition could have affected the overall performance of the device causing the cutting wire to break.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was intended to be used in the papilla during a procedure performed on (b)(6) 2022.During preparation, it was noticed that the handle was stiff so the device would not bow and there were kink marks on the plastic catheter tip.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 wire at the handle section was broken.

• 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: 15839812
• Report Number: 3005099803-2022-06853
• Device Sequence Number: 5846000
• 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): 11/21/2022

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: 03/16/2024
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0029065182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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