Catalog Number SPL40020X |
Device Problems
Burst Container or Vessel (1074); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A sprinter legend balloon catheter was attempted to be used.It is indicated that the device became deformed during use.No patient injury is reported.
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Manufacturer Narrative
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Product analysis summary: the balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear along the balloon working length.The balloon material was jagged and uneven at the tear site.Lead in scratches were not evident proximal or distal to the tear site.Deformation was evident to the distal tip.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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It was reported that the balloon burst during pre-dilatation in the rca.The burst occurred on subsequent inflation.14 atm of pressure had been applied to the balloon prior to the burst.The device was not moved or re-positioned prior to the burst.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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