Catalog Number 1008189-20 |
Device Problem
Material Rupture (1546)
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Patient Problems
Transient Ischemic Attack (2109); Vasoconstriction (2126)
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Event Date 06/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.The 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 the procedure was to treat a de novo lesion with no tortuosity, moderate calcification with 85% stenosis in the internal carotid artery.The viatrac balloon catheter was being used for post-dilation of an unspecified stent.During the procedure, the patient experienced vessel spasm and was given nitroglycerin.During first inflation of the viatrac balloon between 10- 12 atmospheres, the balloon ruptured and the patient experienced a transient ischemic attack (tia).A ct scan was performed immediately after which revealed no significant findings.The tia resolved 1.5 hours post procedure and the patient was discharged home 2 days after procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual and scanning electron microscopy analysis was performed on the returned device.The reported balloon rupture was 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 other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the balloon rupture and subsequent patient effects.
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Search Alerts/Recalls
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