Model Number F5006TWSC |
Device Problem
Torn Material (3024)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/20/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event 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.
|
|
Event Description
|
It was reported that during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient contact.
|
|
Manufacturer Narrative
|
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation and two photos were provided for review.One segment of graft was returned with most of the beading returned.A tear was noted along the beading track of the segment.Therefore, the investigation is confirmed for torn material.The definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: precautions: when removing the external spiral support (beading) of the graft, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and /or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.
|
|
Event Description
|
It was reported that during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient contact.
|
|
Search Alerts/Recalls
|