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

Model Number	M0063903100
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
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 became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Visual analysis of the returned device found the distal portion of the blue/green coating was pulled away from the distal stop, exposing the core wire.There were kinks along the working length of the wire.A functional test was conducted and found that the device could be opened exposing the cone.No issues were noted.Per the directions of use (dfu), "prior to use, ensure that the coil is working properly by advancing the sheath over the coil to the positive stop and then retracting the sheath to open the coil.The sheath of the device should be straight during testing." based on the condition of the device, it is believed that during the procedure, the user had trouble due to operational factors, such as tortuous patient anatomy that prevented the coil from deploying; removing the device through the difficult anatomy with exerted excessive force could result in the kinking along the working length and the green/blue coating getting pulled from the stop.The dfu states "if resistance is encountered while attempting to withdraw the coil do not exert excessive force." therefore, the most probable root cause for this complaint is "failure to follow instructions".Which indicates that the problems are traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in a transurethral lithotripsy procedure performed on an unknown date.According to the complainant, during the procedure, the device was unable to open and close on the first attempt.The procedure was completed with another stone cone coil.No patient complications were reported as a result of this event.Investigation results revealed that the coil was peeled/sheared; therefore, this is now an mdr reportable event.

• 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: 8871384
• Report Number: 3005099803-2019-03957
• Device Sequence Number: 16298097
• 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: Physician
• 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: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1