BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Catalog Number ATG80186 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Stenosis (2263)
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Event Date 08/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.
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Event Description
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It was reported that during an angioplasty of an in stent re-stenosis in the iliac vein, the pta balloon allegedly detached from the catheter shaft during an inflation attempt.Reportedly, the heath care provider (hcp) attempted to retrieve the detached segment using a snare device but was unsuccessful.The hcp decided to send the patient to a local hospital e.R.For removal of the detached balloon segment.The patient was reported as asymptomatic.
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported that during an angioplasty of an in stent re-stenosis in the iliac vein, the pta balloon allegedly detached from the catheter shaft during an inflation attempt.Reportedly, the heath care provider (hcp) attempted to retrieve the detached segment using a snare device but was unsuccessful.The hcp decided to send the patient to a local hospital e.R.For removal of the detached balloon segment.The patient was reported as asymptomatic.
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Search Alerts/Recalls
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