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 Patient Involvement (2645)
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Event Date 08/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: gladiator elite 10.0 x 40, 75 cm 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 a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located approximately at the proximal edge of the proximal transition.A visual and microscopic examination observed no issues with the tip of the device which could potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along 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 balloon rupture occurred.During preparation of a 10.0 x40, 75cm gladiator elite balloon catheter, it was noted that the balloon ruptured.The device was not used and the procedure was completed with a different device.No patient complications nor injuries were reported.
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