Model Number FA-77475-20 |
Device Problems
Break (1069); Kinked (1339); Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation; without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
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Event Description
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Medtronic received information that prior to treatment of an aneurysm, the microcatheter was in place and the physician found the "push rod" was fractured upon opening the package.A new device was used to complete the procedure.No patient injury was reported.
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Manufacturer Narrative
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The device's pushwire was returned for evaluation.The device's braid was not returned.The pushwire within the capture coil were observed to be bent.No damages were found on the tip coil, capture coil, and proximal bumper.The coating of the entire pushwire length was examined was found to be damage at the proximal end.No other anomalies were observed.Based on the analysis findings and the reported event details, the report of fracture could not be confirmed.The device¿s pushwire was not found to be ¿fractured¿.The pushwire was observed to be damaged (bent) within its capture coil.The cause for the damage could not be determined.The coating damage on the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve.The torque device and rhv were also not returned for evaluation; therefore, any contributing factors from the torque device/rhv valve could not be determined.All products are 100% inspected for damage and irregularities during manufacture.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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