Model Number 3520 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/10/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1.Initial reporter facility name- (b)(6) hospital.
|
|
Event Description
|
It was reported that a device contamination occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 330cm rotawire was selected for use.Upon unpacking, a foreign material was noted.The procedure was completed with another of the same device.There were no complications, and the patient is stable.
|
|
Event Description
|
It was reported that a device contamination occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 330cm rotawire was selected for use.Upon unpacking, a foreign material was noted.The procedure was completed with another of the same device.There were no complications, and the patient is stable.
|
|
Manufacturer Narrative
|
E1.Initial reporter facility name-(b)(4).Device evaluated by manufacturer: the device was returned for analysis in its original pouch.Visual and microscopic inspection noted no defects on the returned wire.Inspection of the provided media revealed foreign material in the hoop.The reported event was confirmed.
|
|
Search Alerts/Recalls
|