BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number ATG120184 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348)
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Event Date 11/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2021).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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It was reported that during an angioplasty procedure in the superior vena cava, the pta balloon was allegedly found to be detached.A snare was used to retrieve the detached material, via an alternate access site.No further treatment was needed.There was no reported patient injury.
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Event Description
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It was reported that during an angioplasty procedure in the superior vena cava, the pta balloon was allegedly found to be detached.A snare was used to retrieve the detached material, via an alternate access site.No further treatment was needed.There was no reported patient injury.
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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.Investigation summary: the balloon of the device was returned for evaluation.The catheter and hub was not returned.The balloon segment was examined and signs of detachment were noted at both balloon weld locations.Therefore, the investigation is confirmed for balloon detachment.The definitive root cause for the identified detachment could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.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.(expiry date: 04/2021).
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Search Alerts/Recalls
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