MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number	M0063903100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer has received the device.The complainant was unable to provide the suspect device lot number; therefore the device manufacture date and expiration date are unknown.(b)(4).Visual analysis of the returned device found the cone was broken and there was slight discoloration around the break.Additionally, kinks were noted along the working length.Based on the condition of the device, it is most likely that during the procedure the device came into contact with electrified equipment or a laser.The directions for use (dfu) states "do not directly fire upon the device with a laser." therefore, the most probable root cause for this complaint is failure to follow instructions, which indicates that the problem was traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
Boston scientific corporation received an unauthorized return of a stone cone nitinol urological retrieval coil that was used during a procedure.It was found that the cone was broken, and there was slight discoloration around the break.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: STONE CONE
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8871112
• Report Number: 3005099803-2019-03961
• Device Sequence Number: 19317162
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: M0063903100
• Device Catalogue Number: 390-310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/07/2019
• Patient Sequence Number: 1