Model Number 10619 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Event date unknown.
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Event Description
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It was reported that failure to deflate a balloon occurred.During a percutaneous coronary intervention (pci), a 4.00 x 20 synergy stent was advanced to the target lesion and deployed, but following deployment, the balloon would not deflate.Multiple attempts to deflate the balloon were performed by using an indeflator.It was confirmed that a vacuum was held during withdrawal.The balloon was finally deflated, but a residual pocket at the end of the balloon was noticed.It was noted that the balloon was mostly deflated prior to the removal attempt.The procedure was completed and no patient complications were reported in relation to this event.
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Event Description
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It was reported that failure to deflate a balloon occurred.During a percutaneous coronary intervention (pci), a 4.00 x 20 synergy stent was advanced to the target lesion and deployed, but following deployment, the balloon would not deflate.Multiple attempts to deflate the balloon were performed by using an inflator.It was confirmed that a vacuum was held during withdrawal.The balloon was finally deflated, but a residual pocket at the end of the balloon was noticed.It was noted that the balloon was mostly deflated prior to the removal attempt.The procedure was completed and no patient complications were reported in relation to this event.
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Manufacturer Narrative
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Device evaluated by manufacturer: the synergy ous mr 4.00 x 20 mm stent delivery system (sds) was returned for analysis without the stent as it was deployed successfully at the lesion site.Signs of positive pressure were noted on the balloon cones as the balloon was in a partially deflated state.No bunching of the balloon cones was noted.A functional test was performed, and the device was inflated and deflated within 15 seconds without issues.No issues were identified during the product analysis.
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Search Alerts/Recalls
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