Model Number 24630 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion was in a moderately tortuous and severely calcified superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atm upon third inflation and was removed without any problem.The procedure was completed with another of the same device.No patient complications reported.
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Manufacturer Narrative
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Initial reporter city: (b)(6).
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion was in a moderately tortuous and severely calcified superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atm upon third inflation and was removed without any problem.The procedure was completed with another of the same device.No patient complications reported.It was further reported that the balloon was simply pulled out of the patient's body and the patient was stable post procedure.
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion was in a moderately tortuous and severely calcified superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atm upon third inflation and was removed without any problem.The procedure was completed with another of the same device.No patient complications reported.It was further reported that the balloon was simply pulled out of the patient's body and the patient was stable post procedure.
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Manufacturer Narrative
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E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: 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.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 3mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.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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Search Alerts/Recalls
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