Exemption number e2019001.
The device was not returned for evaluation.
A review of the lot history record and complaint history could not be conducted because the lot number was not provided.
The investigation determined the reported issue appears to be related to operational context.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was performed to treat a target lesion in the heavily calcified and moderately tortuous 1st obtuse marginal artery.
The trek dilatation catheter was advanced without difficulty to the target lesion and inflated twice.
On the second inflation, the balloon ruptured at 14 atmospheres (atm).
The dilatation catheter was removed without resistance.
A second device, an nc trek, was used to complete dilatation.
There was no adverse patient effect and no clinically significant delay.
No additional information was requested.
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