Catalog Number 0684-00-0575 |
Device Problem
Difficult to Advance (2920)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/20/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).
|
|
Event Description
|
It was reported that while attempting to insert an intra-aortic balloon (iab), the guidewire was unable to be inserted through the inner lumen.The customer tried to front and backload it, but midway though the lumen it stopped and would not advance.The iab was replaced and therapy was provided.There was no patient harm or adverse event reported.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint (b)(4).
|
|
Search Alerts/Recalls
|