BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number U8150322 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/08/2018 |
Event Type
malfunction
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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 the inner packaging label referenced a 2mm size balloon and the outer packaging label referenced a 3mm size balloon.There was no patient contact.
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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for the reported packaging issue, as the photo review could not confirm that the 2mm labeled device was packaged within the 3mm labeled outer box.The reported 2mm device lot was manufactured and shipped from the manufacturing site 3 months prior to the 3mm device packaging.Therefore, it is highly unlikely that the reported issue is manufacturing related.It is unknown if a mix-up occurred at the user facility.A definitive root cause for the reported issue could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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Event Description
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It was reported that the inner packaging label referenced a 2mm size balloon and the outer packaging label referenced a 3mm size balloon.There was no patient contact.
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Search Alerts/Recalls
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