ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 63 CM LENGTH, 8F; INTRODUCER, CATHETER
|
Back to Search Results |
|
Model Number 407449 |
Device Problem
Gas/Air Leak (2946)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
During a proximal atrial fibrillation ablation procedure, prior to reinserting the catheter into the sheath, air was aspirated into the syringe that connected to the extension port of the sheath.Several aspirations were attempted, but the issue remained.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
|
|
Manufacturer Narrative
|
One 8f swartz braided introducer sheath was received for evaluation.The dilator was also returned.A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent leak is consistent with damage during use.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.
|
|
Search Alerts/Recalls
|
|
|