Model Number U41502H15 |
Device Problems
Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)
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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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The device was returned for evaluation.It was noted that the tip of the balloon was frayed.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model u41502h15 pta balloon dilatation catheter allegedly frayed and unraveled.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model u41502h15 pta balloon dilatation catheter allegedly peeled and unraveled.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.
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Manufacturer Narrative
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H10: the device was returned for evaluation.The investigation was confirmed for peeling.The definitive root cause could not be determined.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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Search Alerts/Recalls
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