BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number CQ7594 |
Device Problems
Material Frayed (1262); Peeled/Delaminated (1454); Material Deformation (2976)
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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 device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.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 (1) malfunction event.A review of the events indicated that model cq7594 pta balloon dilatation catheter allegedly experienced an asymmetrical shape during inflation.This report was received from one source.This event involved one patient, age, weight and gender were not provided.This patient had no reported patient injury.
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Manufacturer Narrative
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The device has been returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for peeled pebax, fiber disturbance, and deformation of the balloon during inflation.The constricted fibers at the distal cone of the balloon caused the balloon to take the asymmetric shape upon inflation.However, the definitive root cause for the identified fiber constriction or peeled pebax could not be determined based on the available information.The device is labeled for single use.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 (1) malfunction event.A review of the events indicated that model cq7594 pta balloon dilatation catheter allegedly experienced material frayed, peeled layer, and material deformation.This report was received from one source.This event involved one patient, age, weight and gender were not provided.This patient had no reported patient injury.
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Search Alerts/Recalls
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