As reported, a 4f infiniti diagnostic catheter separated in two pieces.The device was broken near the hub.The broken segment was still outside the patient and was retrieved.The entire product was able to be removed with nothing left behind.Another infiniti catheter was used to get the diagnostic heart catheterization procedure completed.There was no reported patient injury.It was during the second injection.A 4f non-cordis sheath was used.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (fu).The target lesion was reported to be the left main coronary artery (lca).Lesion calcification is unknown; there was no vessel tortuosity and the percentage stenosis is unknown.The device was not used for a chronic total occlusion (cto).There was no unusual force necessary during use of the device and no resistance/ friction experienced during any part of the procedure.There was no resistance met while advancing the device.Excessive torquing was not required.The tip was visible on fluoroscopy throughout the procedure.The device was returned for evaluation.
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As reported, a 4f infiniti diagnostic catheter separated in two pieces.The device was broken near the hub.The broken segment was still outside the patient and was retrieved.The entire product was able to be removed with nothing left behind.Another infiniti catheter was used to get the diagnostic heart catheterization procedure completed.There was no reported patient injury.It was during the second injection.A 4f non-cordis sheath was used.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (fu).The target lesion was reported to be the left main coronary artery (lca).Lesion calcification is unknown; there was no vessel tortuosity, and the percentage stenosis is unknown.The device was not used for a chronic total occlusion (cto).There was no unusual force necessary during use of the device and no resistance/ friction experienced during any part of the procedure.There was no resistance met while advancing the device.Excessive torquing was not required.The tip was visible on fluoroscopy throughout the procedure.A non-sterile unit of ¿cath mpac inf 4f jr4/jl4/pig¿ was received for analysis.During visual inspection, the unit was noted to be separated in two pieces, and both segments were returned.The separation is located inside the strain relief approximately 100 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.The separated edges were inspected with the vision system and elongations, diameter reduction, and plastic deformation was observed.No damages or anomalies were observed on the strain relief.The reported ¿catheter (body/shaft) ~ separated¿ was confirmed.The unit was returned separated in two pieces.The exact cause of this damage could not be conclusively determined during the analysis however, the characteristics found on the materials of the unit are commonly associated with separations caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to a tensile/twist forces that exceeded the material yield strength prior to the separation.Procedural and/or handling factors may have contributed to the failure.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.Treat all 4f (1.35 mm) 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.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
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