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Model Number 45-780204-L |
Device Problem
Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformance 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 implanted in the patient and not available to the manufacturer for analysis.Therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
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Event Description
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It was reported that the embolization coil implant was passed through a microcatheter catheter fine and tracked into position and was detached per usual technique.However, when removing the pusher wire, a portion of the coil tracked back into the microcatheter.Reportedly, the physician was able to place the coil in position in the patient.There was no repo of harm or injury to the patient, who was stable.
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Manufacturer Narrative
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The implant was not returned for analysis and was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The pusher was the only component returned for evaluation.The investigation of the returned pusher found the pusher with burn marks on the heater coil, indicating the device was activated using a detachment controller.The monofilament was removed from the pusher's body coil and profiles a mushroom shape tip, which is consistent with a successful detachment.The device was tested with a compatible lab provided v-grip controller and passed the 4-way continuity test.The pusher resistance measured "38.5ohm" (38-52ohm = specification) and the proximal connector measured "ol" (ol = specification).The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.
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Search Alerts/Recalls
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