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Model Number 105-7100-060 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not been returned for analysis as it was implanted; therefore the complaint could not be determined.However as reported, 10mm (1cm) catheter was entrapped by onyx.Per onyx les instruction for use: "do not allow more than 1cm of onyx les reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx reflux or prolonged injection time may result in difficult catheter removal and catheter entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long term effects of an entrapped catheter that is left in a patient is unknown, but could potentially include clot formation, infection, or catheter migration." please reference mdrs 2029214-2016-00897 and 2029214-2016-00898 for the other devices referenced in this event.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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Medtronic received information that after use of the onyx the marathon microcatheter tip became entrapped by onyx and could not be removed.After attempts to remove the catheter, the tip detached 20cm from the distal tip.During procedure to treat the cerebral arteriovenous fistula, the physician used 2 vials of onyx 18 and tried to remove the marathon microcatheter after injection.However, the catheter tip was trapped by onyx, and the catheter was hard to remove.Approximately 10mm of the distal end of the microcatheter was trapped with the onyx.The physician applied tension then loosened repeatedly for 6 minutes.Then the catheter tip got torn and separated at 20 cm from the tip.The physician tried to capture the torn piece with a snare but failed to do so, and the piece was left inside the patient.The procedure was completed without further intervention and no injury to the patient has been 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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Search Alerts/Recalls
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