The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.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.
|
It was reported that during the first inflation in an a/v fistula, an alleged leak was identified at the distal end of the pta balloon catheter.It was further reported that the balloon allegedly would not fully inflate.There was no reported retraction difficulty through the sheath.Upon removal of the balloon catheter from the patient, the health care provider allegedly identified a kink and a hole in the catheter.There was no reported impact or consequence to the patient.
|
After further clinical review, this event was reassessed and determined to be not mdr reportable.Although, this event is not mdr reportable, an initial mdr has already been submitted; therefore, this supplemental report is being submitted to document the change in reportability.Remove: mdr classification: type of reportable event.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.
|