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 11/08/2019 |
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 a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous forearm shunt.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During the procedure, after several dilatations, it was noted that the balloon ruptured.The device was simply pulled out from the patient's body and the procedure was completed with another of the same device.There were no complications and the patient's condition was good post procedure.
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Event Description
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It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous forearm shunt.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During the procedure, after several dilatations, it was noted that the balloon ruptured.The device was simply pulled out from the patient's body and the procedure was completed with another of the same device.There were no complications and the patient's condition was good post procedure.
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Manufacturer Narrative
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Initial reporter city: (b)(6).Device evaluated by mfr: the 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.A blood like substance was identified in the balloon and shaft which is indicative of a balloon leak.A pinhole was located in the mid section of the balloon.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination of the shaft identified no issues.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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