The returned device condition prevented qa from performing detailed bench top evaluation.The complainant left the luer fitting from the packaging coil (the product is secured with a luer on the packaging coil to withstand shipping) and attempted to place the msd.Though this may not have directly contributed to the reported difficulty, it would have prevented proper msd placement and locking.Minor pinch marks were observed on the msd.The microsonic device, partially in-situ in iddc, was damaged near proximal end.When ekos followed up, the complainant reported that they completed the procedure with a similar device and the patient was "ok".Review of the manufacturing records indicate that the product was manufactured according to the specifications and met all acceptance criteria prior to release.The instructions for use (ifu) states that "do not deform or kink the msd during delivery into the iddc.If the msd is kinked at any time, do not attempt to use the msd, as kinking may lead to degraded performance or fracture during use".A definitive root-cause could not be determined at this time.
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