Model Number 3851 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1 - initial reporter city: (b)(6).
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Event Description
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It was reported that a balloon rupture occurred.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that a balloon rupture occurred.The device was removed without any problem using the normal method.The procedure was completed with another of the same device.No patient complications and the patient was good post procedure.
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Manufacturer Narrative
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E1 - initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.No issues were identified with the hypotube shaft.The shaft polymer extrusion had no kinks or damages.A detailed microscopic examination of the balloon material identified a pinhole 2mm proximal from proximal markerband when attempting to inflate the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.An attempt was made to inflate the balloon to 12 atmospheres using the encore inflation unit, however, a leak was noted coming from a pinhole in the proximal section of the balloon.The encore inflation device was verified before and after the procedure using a druck gauge.No other device issues were identified during returned product analysis.
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Event Description
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It was reported that a balloon rupture occurred.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that a balloon rupture occurred.The device was removed without any problem using the normal method.The procedure was completed with another of the same device.No patient complications and the patient was good post procedure.
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Search Alerts/Recalls
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