Model Number FA-55150-1030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Paresis (1998)
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Event Date 09/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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The reported device has not been received.The product was not evaluated, therefore the reported event could not be confirmed.The c ause of the event could not be conclusively determined from the available information.Should the device be received for evaluation, new information shall be submitted in a follow up report.Marksman instruction for use warns: " never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel." linked mdr's 2029214-2017-01200, 2029214-2017-01201, 2029214-2017-01202, 2029214-2017-01203.
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Event Description
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Medtronic received information that a patient had right internal carotid artery dissection and hemiparesis associated with an aneurysm embolization procedure.A flow diversion device was used with a marksman microcatheter for the treatment of the patient's saccular aneurysm located at the right internal carotid artery at ophthalmic segment.The aneurysm measured 6mm in max diameter and 4.10mm in neck diameter and the distal and proximal landing zone artery sizes were 3.4mm and 3.7mm respectively.Vessel tortuosity was described as normal.It was reported the devices were prepared as indicated in the instruction for use.When the flow diversion device was advanced via the marksman microcatheter, severe resistance was met.It was further reported force was applied during delivery of the flow diverter.The flow diverter was locked up at the distal segment of the marksman microcatheter.The devices were removed from the patient.The marksman microcatheter was noted to have been stretched.
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Manufacturer Narrative
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Device evaluation: the marksman catheter was returned for evaluation.Based on analysis, no evidence was found to suggest that the marksman failed to meet specifications.All products are 100% inspected for damage and irregularities during manufacture.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.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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