As reported, a fracture was found on a 6f infiniti judkins right 3.5 100cm guiding catheter during right coronary angiography.It was successfully removed from the patient's vessel.There was no reported patient injury.Multiple attempts to obtain additional information was made without success.The product was not returned for analysis.A product history record (phr) review of lot 18025539 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) cracked in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the event experienced by the customer could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to issue experienced; however, procedural/handling factors are likely.Although not intended as a mitigation of risk, the information for safety within the instructions for use (ifu) is provided in the product¿s labeling with the intent to make the user aware of the risks.As cautioned in the ifu, ¿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.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the phr review nor the information available suggest a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.
|