MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number	35615
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire fracture occurred.The target area was located in the kidney.A.038 accustick ii was selected for use.During the procedure, when the accustick wire was placed in and then the dilator over the wire, it was noted that the wire was kinked.The physician pulled out the wire; however, it unraveled and a portion of the device stayed in the patient's kidney.Consequently, the physician put the inner stiffener over the wire to provide stability and to remove the wire.This was unsuccessful.There was no other option but to remove the wire surgically.No further patient complications were reported and the patient's status post-procedure was fine.

• Brand Name: ACCUSTICK II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8228665
• Report Number: 2134265-2018-64792
• Device Sequence Number: 204167
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K952828
• 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): 01/08/2019

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: 11/11/2021
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0022924867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/08/2019
• 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: Required Intervention
• Patient Age: 73 YR