Model Number UNKNOWN |
Device Problems
Break (1069); Physical Resistance (2578)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The pipeline flex was returned still stuck within the marksman catheter; however, the devices were separated with the distal part of the pipeline flex (pushwire and braid) stuck inside the distal part of the catheter (approximately 22.5cm) and the proximal broken pipeline flex pushwire was stuck inside the proximal broken catheter segment.The total length of the marksman catheter was measured and it was found to be within specifications.The pipeline braid was observed to be partially deployed from the broken end of the distal segment of the marksman catheter.Slight catheter accordion was observed at near the distal tip.The broken end of the distal segment of the marksman catheter was observed to have its braid exposed at 22.5cm from the distal tip.The broken distal and proximal catheter segments had to be dissected to remove the pipeline broken segments from them.The broken end of the proximal segment of the marksman catheter was observed to have its braid exposed and catheter accordion was observed at several locations.Kink was observed near the broken end of the proximal catheter segment.No flash, voids molded, or damages were observed on the catheter hub.Due to the damaged condition of the marksman catheter, the marksman catheter could not be further tested.Please refer to mdr# 2029214-2017-00932 for the marksman catheter.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 during embolization treatment of an unruptured saccular aneurysm measuring 4.5mm located in the left ica (internal carotid artery), the physician felt resistance in the distal section of the marksman catheter as they were trying to deploy the pipeline flex after it was re-sheathed.The pipeline flex became stuck and another pipeline flex and marksman catheter was used to complete the procedure.The vessel was normal in tortuosity and 5mm in diameter.The patient was on dual antiplatelet therapy and there was no patient injury reported.
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Manufacturer Narrative
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The device was made reportable based on the condition of the returned device.Device code updated.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 embolization treatment of an unruptured saccular aneurysm measuring 4.5mm located in the left ica (internal carotid artery), the physician felt resistance in the distal section of the marksman catheter as they were trying to deploy the pipeline flex after it was re-sheathed.The pipeline flex became stuck and another pipeline flex and marksman catheter was used to complete the procedure.The vessel was normal in tortuosity and 5mm in diameter.The patient was on dual antiplatelet therapy and there was no patient injury reported.Based on the returned, device evaluation found the pipeline flex device was separated from the distal end.
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Search Alerts/Recalls
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