Catalog Number FVL10080 |
Device Problems
Break (1069); Positioning Failure (1158); Fracture (1260); Misfire (2532)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2017 |
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 underway.The catalog number identified has not been cleared in the us, but is similar to the name of device products that are cleared in the us.The 510 k number and pro code for the name of device products are identified.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 a stent graft deployment procedure, two vascular stent grafts allegedly failed to deploy from the vascular stent graft delivery systems, and the handle of both delivery systems allegedly broke.Reportedly, a third device was used and the procedure was completed.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.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 complaint that has been reported for this corporate lot number to date.Visual inspection: the sample was not returned; therefore, a 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: as no sample and no images were returned the complaint was closed with inconclusive results.Based on the available information, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment." regarding the anatomy of the placement site the ifu states: "prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy." (b)(4).
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Event Description
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It was reported that during a second attempt to deploy a stent graft during a four stent deployment procedure to treat a tortuous and calcified lesion in the hypogastric artery via the left brachial artery as access, the vascular stent graft allegedly failed to deploy from the delivery system, and the handle allegedly broke.Therefore an attempt was made to remove the device from the patient, and upon removal, the stent allegedly partially deployed in the brachial artery requiring surgical intervention to remove the stent graft.Reportedly, a third device was used and the procedure was continued.The patient was hemodynamically stable at the conclusion of the procedure.
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Search Alerts/Recalls
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