MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire detachment occurred.A 150cm, 8cm poly tip v-18 control wire guidewire was selected for use.However, during procedure, it was noted that the guidewire got separated.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that guidewire detachment occurred.A 150cm, 8cm poly tip v-18 control wire guidewire was selected for use.However, during procedure, it was noted that the guidewire got separated.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the guidewire broke inside the patient's body at a portion near the tip of the device and the device was completely removed.The physician believes that the cause of the detachment was due to a calcified lesion.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8837250
• Report Number: 2134265-2019-08847
• Device Sequence Number: 2389757
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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 Expiration Date: 05/08/2021
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0023766214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1