As the lot number for the device was provided, a manufacturing review 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: 05/31/2022).
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It was reported that during an angioplasty procedure in the cephalic vein, the balloon allegedly ruptured.It was further reported that the device was trapped at the lesion and could not be retracted.Another access site was used to snare the balloon catheter and remove detached material.After the procedure, the patient was bleeding from an access site and was transferred to a hospital for further observation.The patient was reportedly stable.
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