Model Number 181036CS-V-A1-CN |
Device Problem
Component Missing (2306)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/29/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 returned to the manufacturer for analysis and its evaluation is ongoing.
|
|
Event Description
|
It was reported that when the embolization coil was advanced into the microcatheter, the physician noted the coil was missing.No patient injury was reported.Reportedly, the physician did not inspect the coil prior to use.
|
|
Manufacturer Narrative
|
Additional information: h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the pusher's body coil damaged at distal, the introducer distal tip damaged, and the implant separated from the pusher.Further investigation found the coil implant stuck inside the dispenser hoop.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the implant's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.
|
|
Search Alerts/Recalls
|