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Model Number 105-5056 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The marathon micro catheter was returned for analysis.No issues or irregularities were observed with the marathon micro catheter hub.The marathon micro catheter was found to be separated at ~88.1cm from the distal tip.The outer tubing and inner liner were found to be separated at the proximal end of the fluoro marker, retained by the inner wire, at ~88.1cm from the distal tip.The separated ends did not exhibit plastic deformation (jagged edges, necking, stretching).The marathon proximal segment was flushed and water exited from the proximal separated end.No other anomalies were observed.The investigation is not completed.Once the investigation is complete, a supplemental report will be submitted.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 the position of the marker point in the middle of the microcatheter was bent and broken and could not be used normally.The microcatheter¿s material was noted to be separated approximately three quarters from one end.There was no damage to the marker band.The damage was found after opening the package and removing it from the protective cover.The patient was undergoing preoperative embolization of the superior sagittal sinus tumor.The microcatheter was not used.No patient injury was reported as a result of the event.
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Manufacturer Narrative
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Event occurred during an embolization procedure to treat a superior sagittal sinus tumor.The marathon micro catheter was returned for analysis.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed; however, the root cause could not be determined.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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