(b)(4).The customer returned a guide wire assembly for evaluation.The guide wire was returned within the advancer tube.The advancer assembly was returned with the advancer tube partially disassembled.The guide wire was observed to have several kinks towards the distal end of the body and at the center of the body.The distal j-bend was kinked and deformed but intact.Microscopic examination confirmed the kinks in the guide wire body.Offset coils were observed at the kink closest to the distal tip.Both welds were present and were observed to be full and spherical.The guide wire was kinked 8, 25, 201 and 242mm from the distal tip.Offset coils were observed at the kink 8mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that b oth the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked in several locations towards the distal tip.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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