Model Number 24630 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that a balloon leak occurred.A 5.00mm/ 2.0cm/ 90cm peripheral cutting balloon (pcb) was selected for use.During procedure, it was noted that blood was running up balloon shaft when inserted.The device was then removed from the patient's body.When attempting to inflate, fluid was coming out of the balloon.The procedure was completed with a 6.0mm pcb.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: balloon/markerbands: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that a balloon leak occurred.A 5.00mm/ 2.0cm/ 90cm peripheral cutting balloon (pcb) was selected for use.During procedure, it was noted that blood was running up balloon shaft when inserted.The device was then removed from the patient's body.When attempting to inflate, fluid was coming out of the balloon.The procedure was completed with a 6.0mm pcb.No patient complications were reported.
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Search Alerts/Recalls
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