Model Number 00884450385685 |
Device Problems
Material Separation (1562); Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account reports that the dialysis graft was successfully placed on (b)(6) 2019; in (b)(6) 2021, they found that the device tore and migrated to the ivc, and is lodged in the hip/pelvis area.Removal of the device is pending.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Search Alerts/Recalls
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