Model Number 24628 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2019 |
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 a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 6.00mm/ 2.0ccm/ 50cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 6atm for several seconds.The procedure was completed with a different device.There were no patient complications reported.
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Manufacturer Narrative
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E1 - (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 1mm distal to the distal end of the proximal markerband.An examination of the balloon material and proximal markerband 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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Event Description
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It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 6.00mm/ 2.0ccm/ 50cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 6atm for several seconds.The procedure was completed with a different device.There were no patient complications reported.
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Search Alerts/Recalls
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