It was reported that the procedure was to treat a mildly tortuous, mildly calcified de novo left anterior descending artery that was 90% stenosed.The indeflator was connected to a 3x15mm unspecified balloon, but the luminescent gauge of the indeflator did not display the correct value when inflating the balloon.A new 20/30 indeflator was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.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 similar incidents from this lot.It is possible inadvertent mishandling resulted in the reported gauge break however as the device was not returned for analysis the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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