As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 06/2024).Device not returned.
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It was reported that during an angioplasty procedure, the device allegedly had deflation issue.It was further reported that the balloon allegedly got struck in the sheath.Reportedly, the access site was cut using the blade to remove the device.The current status of the patient is unknown.
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