Model Number M0035424080 |
Device Problem
Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that during an endovascular embolization procedure, physician used the coils but the first coil was unable to detach.The subject coil was used as the second coil and detached successfully but it was floating freely inside the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.
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Event Description
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It was reported that during an endovascular embolization procedure, physician used the coils but the first coil was unable to detach.The subject coil was used as the second coil and detached successfully but it was floating freely inside the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.
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Manufacturer Narrative
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H4 manufacturing date ¿ added.D4 expiration date ¿ added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the coil did detach but was free floating inside patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this event of 'main coil migration¿.
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Search Alerts/Recalls
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