Catalog Number 1003327 |
Device Problems
Leak/Splash (1354); Product Quality Problem (1506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is expected to be returned for investigation.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 during a coronary procedure, an indeflator was being used with an unspecified balloon catheter for pre-dilatation.The balloon of the balloon catheter failed to inflate and contrast was noted to pass into the indeflator body [face plate].There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.The investigation determined the reported difficulties appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Device evaluated by mfr device is not available for evaluation.
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Search Alerts/Recalls
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