It was reported that "during the insertion of the introducer, they encountered resistance to introduction.As they pulled out the entire device, they noticed that the guide-wire was bent." no patient harm was reported.A new device was used.The patient's condition is reported as fine.
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It was reported that "during the insertion of the introducer, they encountered resistance to introduction.As they pulled out the entire device, they noticed that the guide-wire was bent." no patient harm was reported.A new device was used.The patient's condition is reported as fine.
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Qn#(b)(4).The customer returned one guide wire for analysis.The dilator(s) involved with this complaint were not returned for analysis.No definite signs of use were observed.Visual analysis revealed one major kink and two slight bends on the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.Visual analysis could not be performed on the dilator(s) involved with this complaint as they were not returned for analysis.The kink in the guide wire measured 743mm from the proximal weld.The guide wire length measured 100.6mm, which is within the specification limits of 98.75cm-101.25cm per the guide wire product drawing.The guide wire outer diameter measured.0375", which is within the specification limits of.0370"-.0385" per the guide wire product drawing.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one major kinks on the guide wire.The guide wire also met all relevant dimensional requirements.Despite this, visual, dimensional, and functional analysis could not be performed on the dilators as they were not returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
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