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 11/01/2019 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.A 7.00mm x 2.0cm x 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured before it reached its nominal pressure.The procedure was completed with another of the same device.No patient complications were reported.
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Event Description
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It was reported that balloon rupture occurred.A 7.00mm x 2.0cm x 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured before it reached its nominal pressure.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 80% stenosed target lesion was in a severely tortuous and moderately calcified arteriovenous fistula.The balloon ruptured at 10 atm upon second inflation and the patient was normal post procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Based on potential hazards/failure modes the following attributes were considered during analysis: a visual and microscopic examination was performed on the returned device.It was noted that approximately 5mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 15mm of the lifted blade and the entire blade pad remained bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 10mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found the shaft to be kinked at approximately 355mm proximal of the proximal balloon sleeve.This type of damage is consistent with excessive force being applied to the delivery system.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.A 7.00mm x 2.0cm x 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured before it reached its nominal pressure.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 80% stenosed target lesion was in a severely tortuous and moderately calcified arteriovenous fistula.The balloon ruptured at 10 atm upon second inflation and the patient was normal post procedure.
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Search Alerts/Recalls
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