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

Model Number	M00535150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(device codes): medical device problem code (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the duodenal papilla during a procedure.The exact procedure date was unknown.During the procedure, when the device exited the scope, it was noticed that the cutting wire of the stonetome broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: STONETOME
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12309306
• Report Number: 3005099803-2021-04043
• Device Sequence Number: 17064231
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2023
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0027158942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1