(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
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 deflation issue; however, the reported separation and difficulty removing the device appear 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 to treat a proximal right coronary artery.
During post-dilatation, after the 4.
0 x 15 mm nc trek was inflated three times, the proximal end of the balloon did not deflate.
An attempt was made to remove the balloon catheter through the guiding catheter, but it could not be removed.
When the balloon was pulled back through the 6f radial sheath, the balloon separated from the outer member.
The separated balloon was removed with the balloon catheter and guiding catheter as a single unit.
The procedure ended at this point.
There was no clinically significant delay in the procedure and no adverse patient effects.
No additional information was provided.
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