FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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Lot Number 0008021673 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Upon device return and inspection, it was observed that the catheter was returned with the slider switch deployed, while the spline cage remained undeployed.Additionally, it was noted that the guidewire lumen was no longer adhered to the tip of the spline cage.Due to the delamination of the guidewire lumen from the tip of the spline cage, deployment of the catheter was not possible.The device was dissected to look for any abnormalities that could have contributed to the delamination of the guidewire lumen.Nothing out of the ordinary was noted.The reported event was confirmed.
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Event Description
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Reportable based on analysis completed on 01mar2024.It was reported that during preparation for an ep procedure the farawave ablation catheter 31mm was selected for use, after opening and rinsing the electrode, the guidewire was inserted.The electrode took the shape of a basket.The shape changing mechanism is not working properly.The slider does not move all the way.It does not take the shape of a flower.The troubleshooting was performed, and the device was replaced.The procedure was completed successfully.No patient complications were reported.The device has been returned.However, analysis of the retuned device revealed that the catheter tip bond failed.
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Search Alerts/Recalls
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