H10: as the lot number for the device was not provided, a review of the device history records 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) 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.H11: section a through f ¿ the information provided by bd represents all 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 bd.H3 other text : device not returned.
|
It was reported that during an angioplasty procedure below the knee via an ipsilateral antegrade approach, there was a resistance felt upon inserting.It was further reported that the catheter shaft of the pta balloon allegedly kinked and detached as the physician applied force to advance.Reportedly, the kink and detachment were allegedly occurred outside the patient.The procedure was completed by using another device.There was no reported patient injury.
|