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

Model Number 35615

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2018

Event Type  malfunction  

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8228665
• MDR Text Key: 132491523
• Report Number: 2134265-2018-64792
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR