Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
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Device returned for investigation.The device lot history record review indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.The event description states trapliner got caught on the hemostasis valve and split apart.The half pipe section was split from the proximal end to the collar transition section.The pushwire separated/delaminated from the halfpipe lumen.The rx shaft was damaged with the lumen bulging out.This is likely due to torque damage.Minor bends were noted on the pushwire.The tip of the catheter had minor damages.The damage noted on the catheter is likely to have occurred during use with other devices and concomitant device interaction.Per ifu, a warning and precaution are stated as of the following: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.A nonconformance request was initiated to investigate the complaint issue.A supplier manufacturing/process issue was noted with the trapliner backbone in addition to operational use of the catheter in the procedure.A supplier corrective action has been issued to capture changes.Teleflex will continue to monitor and trend reports for any similar events.
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