Catalog Number FVM14100 |
Device Problems
Fracture (1260); Retraction Problem (1536); Misfire (2532)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model fvm14100 vascular stent graft allegedly experienced fracture, misfire, and retraction problems.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and gender for the patient were not provided.
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Manufacturer Narrative
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H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation confirmed for the partially deployed stent graft which led to outer sheath fracture.The definitive root cause is unknown.The device is labeled for single use.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified in d2.H10: g4, h6 (device code 1069 - break).H11:section a through f - the information provided by bd 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 bd.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model fvm14100 vascular stent graft allegedly experienced fracture, misfire, and retraction problems.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and gender for the patient were not provided.
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Search Alerts/Recalls
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