No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, 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.Visual inspection: one crosser catheter with a guidewire was returned for evaluation.The catheter was returned with bunching of the outer catheter noted near the distal end of the catheter.The outer catheter was torn at the rapid exchange junction.The guidewire was returned within the inner guidewire lumen and was protruding out the distal tip of the crosser.Functional/performance evaluation: an attempt was made to retract the guidewire from the catheter.However, the guidewire was unable to be retracted.The bunching of the catheter was straightened out and the guidewire still could not be retracted.No further functional testing could be performed due to the poor sample condition.The guidewire and catheter were examined under a microscope and no obvious signs of melting were observed.Conclusion: 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.The guidewire was returned stuck within the catheter;therefore, it is possible that the user perceived the guidewire becoming stuck in the guidewire lumen as the catheter "melting" to the guidewire.Labeling review: the current 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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