Model Number 105-5096-000 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The apollo microcatheter has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during arteriovenous malformation (avm) embolization, the apollo catheter tip detached prematurely.It was reported that the physician flushed the microcatheter, when began to pass the medtronic guidewire, found catheter tip detachment.The physician used another same microcatheter and completed the procedure.The vessel was normal tortuous.No patient injury was reported.
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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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The device was returned for evaluation and the clinical observation was confirmed.As received, the apollo catheter found that the 3.0cm detachable tip detached from the catheter.The apollo usable length was found within specifications.There were not any kink or bends found on the apollo microcatheter.No damages or irregularities were found with the detached tip.Based on the device analysis and reported information, we were unable to determine the cause of ¿tip premature detachment¿.It is possible the tip became weakened during handling subsequently causing the tip to detach upon insertion of the guidewire.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damages and irregularities during manufacture.Per the apollo ifu (instructions for use): ¿inspect the catheter, taking care to not touch or manipulate the tip prior to use to verify that it is undamaged.Always handle the distal end of the catheter with care to avoid damage to the detachment zone and unintended detachment.¿ if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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