Model Number 1012274-20 |
Device Problems
Off-Label Use (1494); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 the trek rx dilatation catheter was prepped per instructions for use (ifu) without issue.There was no difficulty removing the proactive sheath.The device advanced to the left anterior tibial, moderately calcified lesion without unusual resistance.Upon initial inflation at 6 atmospheres, the balloon burst.Device aspirated was performed and the device was removed without further issues.Reportedly, the aspiration was not performed as a precaution and there was no air embolus.Another trek was successfully used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
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Manufacturer Narrative
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Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported balloon rupture was not confirmed; however, the noted longitudinal tear in the inner member and balloon is likely what the account perceived as the reported balloon rupture.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 and/or complaints from this lot.The investigation determined a potential product quality issue based on the noted longitudinal tear in the inner member and balloon which is likely what the account perceived as a reported balloon rupture.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.
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Event Description
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Subsequent to the previous medwatch report filed, the additional information was reported: the balloon burst at 6 atmospheres.There was no device aspiration performed due to this issue and no adverse patient effect.
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Search Alerts/Recalls
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