Catalog Number RFG3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Ulcer (2274)
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Event Type
Injury
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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 has been reported that a patient was treated with a closurefast catheter and an rfg3 generator.The patient has shown inflammatory response and ulcer in all ablation treated areas.
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Manufacturer Narrative
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The rfg3 generator was not returned for evaluation.Four images were received for evaluation: image 1 showed redness on the treated leg image 2 showed redness and swelling of the treated leg image 3 showed redness and blistering of the patient treated image 4 showed labelling of a rfg3 generator.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Evaluation summary: the generator was received for evaluation.Attempts were made to retrieve the data from the sd card but it was discovered that it was defective and the data could not be read.Usd data from the generator was extracted and evaluated.It could be seen that the clf rf cycle finished with low temperature and some rf power (12 to 14 watts).It is possible that this indicates that the catheter may have moved while still in clf rf cycle.The power switch needed to be replaced due to cosmetic damages, and the catheter port needed to be replaced because residue was found inside the port.Update received - no further information available.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: device was returned on (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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