Model Number 400SMTHXSFT0204 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coil).During the procedure, it was reported that the smart coil would not remain in the aneurysm after being deployed.Therefore, the smart coil was removed.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device location is unknown.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
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Event Description
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The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) and anterior communicating artery (acom) using penumbra smart coils (smart coil) and a non-penumbra microcatheter.During the procedure, the physician placed smart coils in the target vessel using the microcatheter.Subsequently, the physician placed another smart coil in the target vessel; however, the smart coil would not remain in the aneurysm after being deployed.Therefore, it was removed.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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