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Model Number F5008TWSC |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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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Event Description
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It was reported that during implantation of the eptfe vascular graft, the graft allegedly tore during beading removal.Reportedly, another device was used to complete the procedure.There was no reported patient injury.
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Manufacturer Narrative
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The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.The device was returned for evaluation.The returned device was noted to have some gouging along the beading track, and a circumferential tear 0.4cm in length.Therefore, the investigation was confirmed for the alleged 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.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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Event Description
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It was reported that during implantation of the eptfe vascular graft, the graft allegedly tore during beading removal.Reportedly, another device was used to complete the procedure.There was no reported patient injury.
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Search Alerts/Recalls
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