MEDTRONIC NEUROSURGERY DELTA SNAP SHUNT ASSEMBLY; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Catalog Number 24027-5 |
Device Problems
Leak/Splash (1354); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 12/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product testing is in progress.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.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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It was reported to medtronic neurosurgery the patient underwent a procedure to replace the device with a device with less resistance.According to the report, during the procedure, the physician noticed small amounts of cerebrospinal fluid around the device and wanted it examined for perforation.Reportedly, there was a partial explant of the device and there was no injury to the patient.
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Manufacturer Narrative
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Additional information received reported that the partial explant was in reference to only a part of the shunt assembly being removed.According to the report, the valve was replaced and both the proximal and distal catheter remained implanted.The returned valve was patent.It met the requirements for siphon, reflux, pressure-flow, and preimplantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.The valve did not meet the requirements for leak testing due to a tear noted in the top of the delta chamber.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing showed no anomalies.All valves are 100% tested at the time of manufacture.
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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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