Model Number 2AF283 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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, after the balloon catheter was introduced into the sheath, air was aspirated.The catheter was advanced further into the sheath and ¿big amounts of air¿ was again aspirated.The sheath, balloon catheter, cables and mapping catheter were all replaced with resolve.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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Product event summary: the catheter was returned and visually inspected and functionally tested.Visual inspection of catheter 2af283/ 08781-93 showed the catheter was intact with no apparent issues.Smart chip verification indicated the catheter was used for one injection.The catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.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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