|
Model Number 400SMTSFT0510 |
Device Problem
Failure to Advance (2524)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-00417, 3005168196-2021-00418.
|
|
Event Description
|
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician was unable to advance a smart coil past its initial position within its introducer sheath; therefore, the smart coil was removed.Next, the same issue occurred with another smart coil and subsequently, the physician kinked the pusher wire.Therefore, this smart coil was also removed.While attempting to detach the next smart coil using the handle, it was reported that the smart coil would not detach.Although the click of the handle was audible and the smart coil appeared to detach, the coil did not detach.The physician made five attempts to detach the smart coil using the handle before manually detaching the smart coil.The procedure was completed using additional smart coils, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.
|
|
Manufacturer Narrative
|
Evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the mid-joint.During functional testing, strong resistance was experienced while attempting to advance the smart coil from its returned position within the introducer sheath and the smart coil could not advance at all.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink and fracture observed near the mid-joint.Further evaluation revealed a detached embolization coil.This damage was likely a result of the pusher assembly fracture.Evaluation of the third returned smart coil revealed that the pet lock was separated on the proximal end of the pusher assembly and the embolization coil was detached.No functional testing could be performed; therefore, the root cause of the detachment issue during the procedure could not be determined.Further evaluation revealed a pusher assembly kink.This damage was likely incidental to the reported complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2021-00417, 2.3005168196-2021-00418.
|
|
Search Alerts/Recalls
|
|
|