BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Catalog Number UNKNOWN CONQUEST |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Stenosis (2263); Insufficient Information (4580)
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Event Date 06/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device not returned.
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Event Description
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It was reported through the results of a clinical trial, that approximately two months post index procedure, the patient developed 90 % of target lesion re-stenosis.A standard pta was used to successfully treat the target lesion.Approximately seven months and twenty-one days later post index procedure, the patient expired due to hospital acquired pneumonia and the cause of the death was not related to the device.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g3.H11: b5.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.H3 other text : device not returned.
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Event Description
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It was reported through the results of a clinical trial, that approximately two months post index procedure, the patient developed 90 % of target lesion re-stenosis.A standard pta was used to successfully treat the target lesion.
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Search Alerts/Recalls
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