The complaint is reported as: "in two instances, dysfunctional catheters were found, in which the guidewire bent and presented difficulty in passing through.On one occasion, it became stuck in the patient.No harm was caused to the patient." the reporter was unaware of how the guidewire was removed from the patient.No medical intervention was reported.It was reported on the third attempt the catheter was successfully placed.The patient's condition is reported as fine.
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(b)(4).The customer report of an unravelled guide wire was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.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 ifu also states, "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".A device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.However, 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: "in two instances, dysfunctional catheters were found, in which the guidewire bent and presented difficulty in passing through.On one occasion, it became stuck in the patient.No harm was caused to the patient.".The reporter was unaware of how the guidewire was removed from the patient.No medical intervention was reported.It was reported on the third attempt the catheter was successfully placed.The patient's condition is reported as fine.
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