Model Number 23295 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/16/2019 |
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 balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 16 atmospheres for 30 seconds, the balloon ruptured.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.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 16 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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E1 - initial reporter address: (b)(6).E1 - initial reporter city: (b)(6).Device evaluated by mfr: 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 which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning approximately 5mm proximal of the proximal markerband and extending approximately 10mm distally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this balloon is 15 atmospheres.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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