An anonymous complaint was posted to the (b)(6) stating, a 5f vertebral 135-degree 100cm tempo catheter dissected three selectively probed cervical arteries and two arteries were occluded.The device was intended to be used for cerebral arteriography to investigate cerebral hemorrhage.Additional information was unable to be obtained.The product was not returned for analysis.A product history record (phr) review of lot 17981425 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the limited information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device or procedural images for analysis, the reported customer event ¿artery dissection¿ and ¿arterial occlusion¿ could not be confirmed, and the exact root cause could not be determined.Dissection is a well-known and extensively documented potential complication of a percutaneous intervention.The physical manipulation inherent in this type of procedure can disrupt the vessel plaque and intima.Vessel characteristics such as calcified lesions or tortuous vessels and/or procedural factors can contribute to a dissection occurring.Arterial occlusion is a potential sequelae of dissection.According to the instructions for use (ifu), although not intended as a mitigation of risk, to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Complications may occur at any time during or after the procedure.Based on the information available and the phr review, 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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