Model Number MV-00410HFLA |
Device Problems
Separation Failure (2547); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A search for non-conformance associated with this 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 returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.
|
|
Event Description
|
It was reported that during treatment of an aneurysm, an embolization coil implant would not detach while positioned in the aneurysm.During an attempt to retract the coil, friction was encountered and the coil implant detached.The coil was entirely within the treatment site and was left in position.There was no reported patient injury or intervention.
|
|
Manufacturer Narrative
|
A search for non-conformance associated with this 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 returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.
|
|
Manufacturer Narrative
|
(h10) remove text from h10 of follow-up 1 (h10) replace with: the non-detachment of the implant was followed by an unexpected detachment upon retraction.The monofilament of the implant detached at the attachment bond area of the pusher, which was a result of the retraction forces.This is seen in the void in the attachment area where the monofilament should be fixed.The physical evaluation of the device could not identify the conditions or circumstances that led to the damages, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure 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.
|
|
Search Alerts/Recalls
|