Lot Number 0032272644 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/12/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarx fit catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.
|
|
Manufacturer Narrative
|
Additional information added to b5: describe event or problem.It was indicated that the device will not be returned for evaluation.It was further reported via additional information that the device became unsterile while being handled by the nurse during preparation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarx fit catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.It was further reported that the catheter was looped on the patient field.It became unsterile when unwrapped and it hit the scrub nurse in the head.
|
|
Search Alerts/Recalls
|