BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number CQ5072 |
Device Problems
Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)
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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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One device was returned to bd for evaluation.The company is still investigating the issue at this time.
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Event Description
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This report summarizes one malfunction event.A review of the events indicated that model cq5072 pta balloon dilatation catheter experienced frayed material, a peeled outer layer, and unraveled material.This report was received from one source.This event involved one patient with no patient consequences.The patient was a (b)(6) year old male, weighing (b)(6) pounds.
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Manufacturer Narrative
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H10: of the one device, lot number was provided, and lot history review was performed.Peeled pebax and frayed fibers was identified.A root cause has not been determined.The device was labeled for single use.H10: g4 h11: h6 ( results, conclusion) 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 event.A review of the events indicated that model cq5072 pta balloon dilatation catheter experienced frayed material, a peeled outer layer, and unraveled material.This report was received from one source.This event involved one patient with no patient consequences.The patient was a 61 year old male, weighing 197 pounds.
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Search Alerts/Recalls
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