The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the mfr for eval.The investigation is currently underway.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.
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The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device returned was severly damaged severe bunching of the outer catheter and guidewire was noted.The outer catheter was torn and the inner guidewire lumen was protruding from the outer catheter.The guidewire was returned within the inner guidewire lumen and was protruding out the distal tip of the catheter.The guidewire was able to be removed once the bunching of the inner guidewire lumen was straightened out.The investigation is inconclusive, as functional testing could not be performed due to the poor sample condition and no obvious signs of melting were found on the catheter or the guidewire.Per the reported event details, there were 15 events from the same user over a short period of time where the guidewire melted to the catheters during activation.The user's flowmate injector and generator were replaced with new units and the problem has not been experienced since.Therefore, it is possible that the flowmate injector and/or the generator contributed to the reported events however, based upon the available information the definitive root cause is unknown.The crosser instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.
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