Model Number 24628 |
Device Problems
Material Rupture (1546); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2019 |
Event Type
malfunction
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous shunt.A 5.00mm/2.0cm/50cm peripherial cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured at 6atm upon first inflation for 1 second.The balloon was then simply removed from the patient's body.No complications were reported and the patient's condition was good.
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Manufacturer Narrative
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Lot number updated from 0023758025 to 0023150629.Expiration date updated from 05/07/2021 to 01/07/2021.Unique identifier (udi) # updated from (b)(4) to (b)(4).Device manufacture date 05/08/2019 to 01/08/2019.Device evaluated by manufacturer: 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.One of the cutting blades was lifted from the balloon material.Analysis noted that approximately 6mm of the cutting blade is still attached to the distal end of the balloon, and the remaining section of blade is lifted upright from the balloon material.All the blade pads were noted to be attached to the balloon material.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm distal from the distal edge of the distal markerband.An examination of the balloon material and blades identified no issues which could potentially have contributed to this complaint.No issues were noted with the tip section of the device.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous shunt.A 5.00mm/2.0cm/50cm peripherial cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured at 6atm upon first inflation for 1 second.The balloon was then simply removed from the patient's body.No complications were reported and the patient's condition was good.It was further reported that the blade was noted lifted after the device was removed from the sheath.It was then further reported that the blade lift occurred after the device was removed from the patient.
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Manufacturer Narrative
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D4.Lot number updated from 0023758025 to 0023150629.D4.Expiration date updated from 05/07/2021 to 01/07/2021.D4.Unique identifier (udi) # updated from (b)(4).H4.Device manufacture date 05/08/2019 to 01/08/2019.
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous shunt.A 5.00mm/2.0cm/50cm peripherial cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured at 6atm upon first inflation for 1 second.The balloon was then simply removed from the patient's body.No complications were reported and the patient's condition was good.It was further reported that the blade was noted lifted after the device was removed from the sheath.
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Search Alerts/Recalls
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