Complaint conclusion: as reported, the head of the 4f 0.038 80cm hepatic tempo angiographic catheter was deformed (kinked/bent); it cannot be passed through the lesion.There was no reported patient injury.The device was used inside the patient.A little resistance was met while advancing the device and withdrawing the device.The intended procedure/target lesion was the carotid artery.The lesion was not calcified nor tortuous and had no vessel angulation.The percentage of stenosis was 70%.The device was used for a chronic total occlusion (total occlusion >3 months).The device was resterilized.There were no anomalies noted when removed from the package.No excessive force was required.The device was removed from the patient as normal.One non-sterile unit of a tempo catheter (4f tempo 0.038 80cm hepatic) was received for analysis.During the visual inspection, a kinked/bent segment was found located approximately from 73.6 to 76.5 cm from distal tip.No other anomalies were found along the device.No other component was returned for analysis.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od).Measurements were taken near the damages.Additionally, od¿s were measured on the tip/brite tip and dimensional analysis results were found within specification.A product history record (phr) review of lot 17886054 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft) ¿ withdrawal difficulty - from vessel¿ was not confirmed since it could not be evaluated due the nature of the complaint.The reported event by the customer as ¿brite tip/distal tip ¿ kinked/bent - in patient¿ was not confirmed since the kinked/bent condition was found on the body/shaft of the catheter.Dimensional analysis was found within specification.The exact root cause of this condition could not be conclusively determined during the analysis.Vessel characteristics (70% stenosis, cto) or procedural/handling factors (resterilization) might have contributed to the reported conditions on the unit.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿this product is designed and intended for single use.It is not designed to undergo reprocessing and re-sterilization after initial use.Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.¿ ¿exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.
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