Model Number 7590 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2019 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 79% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.
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Event Description
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It was reported that balloon rupture occurred.The 79% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.
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Manufacturer Narrative
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D4 batch lot number updated to 0024369090.H4 device manufacture date updated to 09/03/2019.Device evaluated by mfr.:returned product consisted of a maverick 2 balloon catheter.Microscopic examination revealed that the hypotube had numerous kinks.A test inflation device was connected to the hub and pressurized inflating the device to rated burst pressure 12atm.The device maintained pressure for 5 minutes with no leaks or irregularities.
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Search Alerts/Recalls
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