Catalog Number 1011707-38 |
Device Problems
Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a lesion located in the left anterior descending coronary artery that was heavily calcified and 95% stenosed.After multiple failure to cross attempts, the proximal shaft was bent and during retraction, with resistance, the proximal shaft separated outside the patient.Another stent was used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.
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Manufacturer Narrative
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The device was received for evaluation.A visual and dimensional inspection was performed on the returned device.The reported material separation and bent shaft was confirmed.The reported failure to advance and difficult to remove could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed and analysis of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: device code 2889 - removed.
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Search Alerts/Recalls
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