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Catalog Number F7008TWSC |
Device Problem
Torn Material (3024)
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Patient Problem
No Patient Involvement (2645)
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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 device is not available for return.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.
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Event Description
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It was reported that during preparation, upon removal of the beading from the vascular graft, the graft allegedly tore.There was no patient contact.
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Manufacturer Narrative
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Manufacturing review: the device history record (dhr) for lot this number was reviewed and the lot met all release criteria.The dhr review showed that all process parameters were within specification and that this lot of grafts passed all physical testing requirements.Visual inspection: the sample was not returned; therefore, visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was not returned.Images and medical records were not provided.The investigation was inconclusive for the alleged graft tears.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu states: precaution: 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 preparation, upon removal of the beading from the vascular graft, the graft allegedly tore.There was no patient contact.
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Search Alerts/Recalls
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