As reported, a 5f tempo universal flush 65 cm diagnostic catheter pierced the non-cordis guide catheter during its ascent to perform the crossover.The guide and the device were removed simultaneously and the catheter had to be cut into 3 pieces to be able to remove it.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
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As reported, a 5f tempo universal flush 65 cm diagnostic catheter pierced the non-cordis guide catheter during its ascent to perform the crossover.The guide and the device were removed simultaneously and the catheter had to be cut into 3 pieces to be able to remove it.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A unit of a catheter cath tempo 5f uf 65cm 5sh was received for evaluation.During the visual inspection it was observed that the unit¿s body presented with a rough damage on the distal end from what appears to be a distal end separation.The distal portion that appears to be separated was not returned for this evaluation.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis was completed by flushing the unit where the water flow exited from the distal end of the unit as expected.No additional leaks were noted along the unit¿s body.A high magnification visual analysis was executed using the vision system on the separated portions.Plastic deformation and elongations were observed near the separation border.The complaint reported by the customer as ¿catheter (body/shaft) - puncture/cut¿ could not be confirmed because only one section of a separated catheter was returned and it did not show any signs of a pierced condition.The event ¿catheter (body/shaft) ¿ separated¿ was confirmed as the device was returned with the distal portion missing.The exact cause of the separation cannot be determined by the analysis however, plastic deformation and elongations are defects commonly caused from exposure to an overloading tensile strength.It was reported the device was cut into 3 pieces therefore, this is a potential cause of the separation.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
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