Model Number 2AF284 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Event summary: upon visual inspection of balloon catheter 2af284 / 05920-61, results showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter has been used for six injections.Performance test did not show any system notice.Dissection showed that guide wire lumen kinked on 1.4390 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.In conclusion, the reported issue has been 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, the balloon was bent at the distal end.The balloon catheter was replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.On (b)(6) 2018: the balloon catheter subsequently tested out of specification per the manufacturer's investigation.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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