Medical device manufacturer,Medtronic Inc., has initiated a medical device field safety correction action concerning specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, models ARCSJ200W, ARCSJ260W and ARCDJ260W.
Medtronic has identified an issue involving the affected products, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. As a result, Medtronicis recalling the affected guidewires.
As of 1 Feb, 2013, Medtronic has received 9 reports involving 14 guidewires related to this issue; 4 of these reports involved serious injury.There were no patient deaths and no additional reported clinical sequelae related to these reports. In Hong Kong, the local supplierhas not been aware of any adverse incident related to the above mentioned issue.
Based on these reports, the overall failure rate of affected guidewires is approximately 0.1% for the kinking or breaking in-vivo.Corrective actions to the manufacturing process have been taken to prevent recurrenceof this issue in subsequent production.
The manufacturer advises that patients should continue to be managed in accordance with the standard patient management protocol andthe guidewireInstruction forUse.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 22 March 2013