ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
|
Back to Search Results |
|
Model Number D-AVHD-DF16 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/31/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The pellethane tubing and splines were corrugated and torn.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn tubing remains unknown.
|
|
Event Description
|
This report is to advise of torn tubing and splines noted during analysis.
|
|
Search Alerts/Recalls
|
|
|