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Model Number 105-5056 |
Device Problems
Burst Container or Vessel (1074); Material Rupture (1546)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Foreign Body In Patient (2687); Unspecified Nervous System Problem (4426)
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Event Date 06/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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Note: the lot numbers for the marathon catheters used are a355343/a400089.It has not been reported which lot number applies to the subject device.Product return has been requested, however the device has not been received.The cause of the reported event has not yet been determined at this time, but further investigation is ongoing, including a proposed inspection of the catheter and any of its contents.However, based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.Mdrs from this event: 2029214-2017-00892 and 2029214-2017-00893.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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The user facility reported to medtronic that an avm (with sca supply) treatment onyx "seeped out" of this catheter due to what is interpreted to be a "micro hole" in the middle side.It was reported that the catheter "continued to split" and onyx embolized the anterior inferior cerebellar artery (aica), along the catheter to the superior cerebellar artery (sca) and in the basilar artery (ba).It was reported the basilar portion was retrieved with a stent retriever.It was further reported the patient exhibited left aphasia, with the gaze not aligning and a 6th and 7th nerve palsy post procedure.Medtronic has not yet had an opportunity to inspect the catheter or confirm the description of the rupture.
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Manufacturer Narrative
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H3: the marathon microcatheter was returned for analysis.Onyx residue was found within the marathon catheter hub.No damages were found with the marathon catheter hub.The marathon catheter body was found kinked at ~133.0cm from the proximal end of the catheter hub.The marathon catheter distal tip marker was found damaged (crushed).What appears to be onyx was found occluding the marathon catheter distal tip lumen.The entire catheter surface was examined under magnification.No catheter ruptures or punctures were observed.The marathon catheter total length was measured to be ~172.2cm (reference: 170cm), the catheter usable length was measured to be ~166.2cm, which is within specification (specification: 165.0 ± 2.5cm), and the catheter distal length was measured to be ~25.8cm which is within specification (specification: 25.0 +2.0cm -1.0cm).Based on the device analysis and reported information, the customer¿s ¿catheter rupture with onyx¿ report could not be confirmed.Although the returned marathon microcatheter was found occluded with onyx, no ruptures or punctures that would lead to a leakage of onyx were found with the marathon catheter body.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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