Qn# (b)(4).Returned was a radial artery catheterization device consisting of a guide wire advancer tube, a guide wire, a catheter, and an introducer needle.The device showed evidence of use.The device was returned with a portion of the guide wire advanced out the distal end of the needle bevel.The swg handle was approximately half way down the advancer tube.The exposed guide wire appeared to have multiple kinks.Microscopic examination confirmed that the exposed guide wire had multiple kinks and offset coils between.The distal weld was present and appeared full and spherical.Damage was also observed on the catheter tip which remained on the needle.The deformed material that was observed is consistent with damage that would occur as the catheter is advanced into the patient.The needle appeared typical with no defects or anomalies.The device was returned with 25 mm of the guide wire was advanced out of the needle bevel.Several kinks and offset coils were located between 85-110 mm from the distal tip of the guide wire.The needle and guide wire met all relevant dimensional specifications.The guide wire was able to be fully retracted into the needle, however, dried blood and guide wire damage prevented the guide wire from easily being advanced back and forth through the needle cannula.(con't).A manual tug test confirmed the distal weld was intact.A device history record (dhr) review was performed on the device including the guide wire and needle cannula and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit contains suggested techniques for guide wire insertion to prevent damage.The ifu cautions that if resistance is encountered while advancing spring-wire guide do not force feed.It also warns to not retract spring-wire guide against edge of needle while in vessel to minimize the risk of spring-wire guide damage.The report of a kinked guide wire was confirmed through examination of the returned sample.The catheterization device was returned with the guide wire advanced out of the needle bevel.The exposed guide wire had multiple kinks and offset coils adjacent to the distal weld.The needle and guide wire measured within specification for all relevant dimensional requirements.A dhr review was performed and it did not reveal any manufacturing related issues.Based on the nature of the damage to the wire and the information reported, 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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