Model Number 3851 |
Device Problems
Difficult to Remove (1528); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that removal difficulty occurred.A 10 mm x 2.75 mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated three times at 24 atm after inflation at nominal pressure.After complete deflation of the device, resistance was encountered during removal.The wire came out along with the balloon indicating that the lumen was crushed and the wire was crimped.The procedure was completed and there was no patient injury reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.A visual and tactile examination identified multiple kinks along the hypotube.A visual and tactile examination identified no kinks or damages.A visual examination of the balloon identified no damages.There was build-up of contrast media present inside the balloon.A microscopic examination of the distal identified no damages.A detailed microscopic examination of the balloon material identified no damages.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no damage.It was possible to load a 0.014 inch size guidewire through the tip and wire lumen with no resistance noted.
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Event Description
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It was reported that removal difficulty occurred.A 10 mm x 2.75 mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated three times at 24 atm after inflation at nominal pressure.After complete deflation of the device, resistance was encountered during removal.The wire came out along with the balloon indicating that the lumen was crushed and the wire was crimped.The procedure was completed and there was no patient injury reported.
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Search Alerts/Recalls
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