(b)(4).The actual device was not returned; however, the customer provided a photo for analysis.The complaint of a peel-away sheath body damaged was able to be confirmed by the photo.The distal tip of the sheath appeared damaged/deformed.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer, and one finding was identified.A non-conformance initiated for lot 34c22h0277 in regard to "peel-away sheath tears incorrectly".Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same as/relevant to the non-conformance identified.Investigation from the non-conformance stated that the failure mode cannot be identified as related to procedures not being followed, only awareness meeting was held with personnel for the nonconformance.Escalated investigation was initiated and found no increase in risk level from previous estimates for sample population.Investigation is ongoing to further investigate potential root causes at the manufacturing site.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 catheter component damage or breakage.Do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." teleflex will continue to monitor and trend for reports of this nature.
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