(b)(4).The customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.The customer returned one, unopened sac kit for evaluation.The kit was opened to further inspect the returned components.Visual inspection of the returned guide wire revealed two kinks throughout the body.Creasing was observed on the guide wire protective tubing, the catheter, and the kit packaging, in the same approximate locations as the guide wire kinks.Microscopic examination confirmed the damage.Both welds were present and appeared full and spherical.The damage observed is consistent with defects related to storage and shipping.The lidstock clearly states "do not bend".The kinks in the guide wire were located 75mm and 92mm using a calibrated ruler from the proximal end.The guide wire total length measured 350mm using a calibrated ruler which is within the specifications of 345mm-355mm per internal product drawing.The guide wire outer diameter (od) measured 0.51mm using a calibrated caliper which is within the specifications of 0.508mm-0.533mm per internal product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit (f-04020-106b rev.02) which states, "insert desired tip of spring-wire guide through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).Thread tip of indwelling catheter over spring-wire guide." the undamaged portions of the guide wire were threaded through a lab inventory 20 ga introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were attached.The manufacturing site was previously consulted regarding the observed failure mode for related complaints.They indicated that the observed kink, in addition to the creasing in the packaging, is consistent with damage caused by shipping and handling.As part of the guide wire manufacturing process, each guidewire is passed through a ring gauge so it is unlikely that this defect would have been present prior to release from the manufacturing site.A device history record review was performed with no relevant findings.In conclusion several kinks were observed on the guide wire body.In addition, several folds and creases were observed on the outside packaging.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.The lidstock clearly states "do not bend." based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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