Model Number MV-80827HHFA |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded by the user facility and not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
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Event Description
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It was reported that when an embolization implant coil was removed from its dispenser hoop, the introducer sheath remained in the hoop.The introducer sheath was placed back on the device after the coil was confirmed to be intact and the coil was used to treat a direct ccf.The coil was delivered to the target lesion, however, resistance was noted during advancement out of the tip of the microcatheter.When attempting to withdraw the coil, the coil became unraveled.After further withdrawal of the unraveled coil, the coil detached unexpectedly at the detachment point.The coil was partially in the lesion and partially in the microcatheter.The coil and microcatheter were removed from the patient using a goose neck snare.Subsequently, the procedure was completed successfully.There was no injury to the patient.
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded by the user facility and not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
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Event Description
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It was reported that when an embolization implant coil was removed from its dispenser hoop, the introducer sheath remained in the hoop.The introducer sheath was placed back on the device after the coil was confirmed to be intact and the coil was used to treat a direct ccf.The coil was delivered to the target lesion, however, resistance was noted during advancement out of the tip of the microcatheter.When attempting to withdraw the coil, the coil became unraveled.After further withdrawal of the unraveled coil, the coil detached unexpectedly at the detachment point.The coil was partially in the lesion and partially in the microcatheter.The coil and microcatheter were removed from the patient using a goose neck snare.Subsequently, the procedure was completed successfully.There was no injury to the patient.
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Search Alerts/Recalls
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