Model Number 39345-351510 |
Device Problems
Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery.A 3.5mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 12atm for 1 minute.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported and patient was good post procedure.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.The returned device was attached to a boston scientific encore inflation unit and the balloon was inflated to its rated burst pressure of 12 atmospheres no leaks or issues noted with balloon material.As per wolverine pi eifu (japan) the rated burst pressure for this device is 12 atm.The markerbands and blades and tip section of the device were visually examined, and no issues were noted with the markerbands, blades or tip of the device.All blades were present and fully bonded to the balloon material.A visual and tactile examination of the polymer extrusion found multiple kinks.This concludes the product analysis.
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Event Description
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It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery.A 3.5mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 12atm for 1 minute.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported and patient was good post procedure.
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Search Alerts/Recalls
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