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 11/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).
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Event Description
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It was reported that the balloon ruptured.The 50% stenosed target lesion was located in the severely tortuous and moderately calcified mid-proximal left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 4 atmospheres.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 1 -(b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.Solidified blood was present inside the balloon material.The device was placed in the waterbath to allow the blood to soften.Once removed, the returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located at 4mm distal to the distal edge of the proximal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine ifu.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination identified no issues.A visual and tactile examination identified no issues.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that 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 50% stenosed target lesion was located in the severely tortuous and moderately calcified mid-proximal left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 4 atmospheres.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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