BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24686 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/03/2019 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the second inflation to 10atms the balloon ruptured.A second 12x40 gladiator elite balloon was pulled to treat the distal part of the stent lesion and when inflated to 10atms, the balloon ruptured.The procedure was completed with another of the same device.No harm was caused to the patient.
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Manufacturer Narrative
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Device evaluated by mfr.: the complaint 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 14mm proximal of the proximal 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 found no issues with the tip or markerbands that could potentially have contributed to the complaint incident.Visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were noted with the device during analysis.
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Event Description
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It was reported that balloon rupture occurred.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the second inflation to 10atms the balloon ruptured.A second 12x40 gladiator elite balloon was pulled to treat the distal part of the stent lesion and when inflated to 10atms, the balloon ruptured.The procedure was completed with another of the same device.No harm was caused to the patient.
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Search Alerts/Recalls
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