(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
The customer reported the device was discarded.
Investigation is not yet complete.
A follow up report will be submitted with all relevant information.
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It was reported this was a below-the-knee procedure.
The armada 14 percutaneous transluminal angioplasty balloon catheter was inflated twice, and after the second inflation, the balloon could not be seen during x-ray with contrast, only the markers.
The balloon was deflated and removed, and the procedure was completed.
The balloon was inflated outside the body for a third time and inflated with no problems.
There was no indication of a leak or a rupture.
There was no reported adverse patient effect or a clinically significant delay in the procedure.
No additional information was provided.
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