The complaint is reported as: physician inserting three lumen cvc.Had no issue inserting the cvc and flushing medial and proximal ports.When trying to flush the distal port had issues removing the spring wire guide, kept catching.During removal, the guidewire "broke" and had to be clamped.The entire cvc was removed.No patient harm was reported.The patient's condition is reported as fine.
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(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The photos revealed a swg fully inserted into a 3-l catheter that contained a major kink at its distal end.Unraveling was evident at the proximal end of the guide wire; however, it could not be confirmed if the guidewire was separated from the photos.The damage to the guide wire was confirmed by the customer provided photo; however, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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The complaint is reported as: physician inserting three lumen cvc.Had no issue inserting the cvc and flushing medial and proximal ports.When trying to flush the distal port had issues removing the spring wire guide, kept catching.During removal, the guidewire "broke" and had to be clamped.The entire cvc was removed.No patient harm was reported.The patient's condition is reported as fine.
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