Model Number 2AF283 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryoablation procedure, when the physician inflated the balloon catheter, the balloon bent.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Event summary: upon visual inspection of catheter 2af283/06457-116, results showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for four applications on the date of the event.The catheter failed the performance test due to system notice # 50005, indicating that the safety system detected fluid in the catheter and stopped the injection.The dissection/pressure test showed a guide wire lumen kink inside the balloons at 1.4 inches from the tip of the catheter.Pressure test did show leaks from guide wire lumen breach.In conclusion, the reported issue (balloon bend (gwl) was confirmed through testing.The balloon catheter failed the returned product inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, when the physician inflated the balloon catheter, the balloon bent.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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