Model Number FX466T |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Hydrocephalus (3272)
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Event Date 12/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported that a progav 2.0 with ped.Prechamber (part # fx466t) was to be used during a shunt implant procedure performed on (b)(6) 2022.According to the complainant, the catheter was loose and separating from the reservoir.The issue was noted when the device was removed from the box.No surgical delay or patient impact occurred as a result of the event.
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Manufacturer Narrative
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Investigation: visual inspection: the following observations were made during the visual inspection: bloody residues on the ligature.Scratches on the pediatric prechamber.Kink protection shifted.A tensile test was performed.No abnormalities were detected during the test.The spout and the catheter are fixed in place.Results: based on our investigation results, we can detect a displacement at the kink protection.However, the shift has no impact on the function of the device.We can exclude a defect at the time of release.The product met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
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Search Alerts/Recalls
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