Complaint conclusion: as reported, a 5f multipurpose a1(l) 125cm tempo diagnostic catheter was found to be "broken" in several places outside the patient's body.The procedure was completed by using an unknown contrast catheter.There was no reported patient injury.The device was intended to be used for a lower extremity arterioplasty.The angiography catheter was found to have several damages after unpacking.The anomalies were noted before use.The device was inspected prior to opening the package.The device was intended for use in a diagnostic procedure.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The user was trained to the device.The device was going to be used for treatment of a chronic total occlusion (cto).A unit of catheter cath tempo 5f mp a1(l) 125cm was received for analysis.Multiple cracked areas were noted during visual inspection.Outer diameter (od) measurements were taken near the damages and were found within specification.A high magnification visual analysis was executed using the vision system and scratch marks were observed near the damaged sections.The complaint reported by the customer as ¿catheter (body/shaft) - cracked¿ was confirmed since this condition was present on the device.Scratch marks are commonly attributed to an interaction between the affected surface and sharp-edged materials.Therefore, it is possible the interaction that resulted in the scratch marks could be related the cracked conditions.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ 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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