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

Model Number	40535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal tip detachment occurred.The target lesion was located in the mildly tortuous and severely calcified right common femoral artery.A 300 cm, 12 cm v-18 control wire guide wire was crossed the lesion.However, the distal tip at around 9 cm of the wire sheared off inside the patient.The fragment was left in the subintimal space.No intervention was done in an attempt to remove the sheared component.The physician noted that the fragment was not in jeopardy of migrating and it would not cause any harm; therefore, the physician decided that it was best to keep it there.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable and good.

• 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: 7846214
• Report Number: 2134265-2018-60788
• Device Sequence Number: 16481479
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: 08714729070238
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0021168771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other