As the lot number for the device was not provided, a manufacturing review could not 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) 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.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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It was reported that during a tavr procedure, the balloon allegedly ruptured during an inflation attempt.It was further reported that there was difficulty retracting the balloon through the 14fr sheath.Upon removing the balloon and sheath together as one unit, a segment of the balloon material allegedly detached and became lodged in the external iliac artery.Multiple attempts to remove the balloon segment including upsizing to a 16fr sheath and the use of a snare were unsuccessful.The health care provider decided to send the patient to surgery for removal of the balloon segment.There was no reported patient injury post surgical extraction of the balloon segment.
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