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Date of event - estimated.
The unique device identifier (udi) is unknown because the part number and lot number were not provided.
The device was not returned for evaluation.
A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.
The investigation was unable to determine a conclusive cause for the reported complaints.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
The gw referenced is filed under a separate medwatch report number.
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It was reported that the procedure was to treat an unknown lesion.
A 014 hi-torque pilot guide wire (gw) was advanced and positioned.
Next, the unspecified abbott balloon dilatation catheter (bdc) was advanced over the pilot gw, towards the target lesion.
Once the bdc was next to the target lesion, the guide wire and bdc became stuck together and the bdc could not be advanced further or removed from the guide wire.
The unknown abbott bdc and the pilot guide wire were removed from the anatomy as a single unit.
Once the devices were removed, the devices became unstuck from each other.
A new guide wire and balloon dilatation catheter were used to successfully complete the procedure.
There was no reported adverse patient effect or a clinically significant delay in procedure.
No additional information was provided.
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