Catalog Number 1013466-100 |
Device Problem
Defective Device (2588)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number e2019001.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a moderately calcified proximal superficial femoral artery that was 90% stenosed.During post-dilatation, a 4x100mm armada balloon dilatation catheter was inflated 4-5 times at unspecified atmospheres when it was noted that the balloon did not inflate the entire length of the previously implanted stent as expected, but continued to use it to complete stent apposition.The balloon is reported to be miss-sized in accordance with the labeled size.There were no issues with the actual balloon inflation.Once removed out of the anatomy, it was noted that the balloon was shorter than it should be.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual and dimensional analysis was performed on the returned device.The reported undersized balloon was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no indication of a lot specific product issue.The investigation determined that the device met specification.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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