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

Model Number	40495
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire coating sheared off and the profunda was punctured.The target lesion was located in the profunda femoris artery.A non-bsc micropuncture kit was used to access the artery.Then a 150cm, 8cm v-18 control wire was advanced through the micropuncture kit.However, while repositioning the wire, the hydrophilic coating of the wire sheared off in the vessel.Snaring attempts were made but they were unsuccessful.Therefore the fragments were left inside of the patient and the procedure was stopped.It was also reported that the profunda was punctured during the procedure.No further patient complications were reported.

• 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: 8102051
• Report Number: 2134265-2018-63183
• Device Sequence Number: 13727653
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/26/2018

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: 07/20/2020
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0022409210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDLINE MICROPUNCTURE KIT
• Outcome Attributed to Adverse Event: Other; Required Intervention