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

Model Number M0063903100

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2019

Event Type  malfunction  

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 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
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 1525 hertz street; chihuahua ; MX
• Manufacturer Contact: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8871112
• MDR Text Key: 153676918
• Report Number: 3005099803-2019-03961
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1