Model Number 3851 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that the balloon was fractured.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted the balloon was fractured and was removed directly from the patient's body.The procedure was completed with another of same device.No complications reported and patient was stable post procedure.
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Event Description
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It was reported that the balloon was fractured.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted the balloon was fractured and was removed directly from the patient's body.The procedure was completed with another of same device.No complications reported and patient was stable post procedure.
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Manufacturer Narrative
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F10- device code updated.Device evaluated by mfr: the device was returned for evaluation.There was a complete hypotube break present at 44 cm distal the end of the strain relief.A visual examination identified that the balloon folds were in a wrapped state and had not been subject to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified a complete break at 42 cm distal to the strain relief.Multiple hypotube kinks was also identified.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.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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