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 Problems
Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/27/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.Visual inspection on the complaint device noted the distal coupler was fractured and detached.In addition, the nitinol frame and wires were torn.The catheter was inserted and withdrawn from a stock 8.5f sheath with no resistance or anomalies noted.The instructions for use states ¿insert the distal tip section of catheter into an 8.5 f minimum introducer (not included) using the insertion tool.¿ an 8.0f sheath was used during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn wires and frame and the fractured and detached distal coupler is consistent with incorrect use of the device.
|
|
Event Description
|
This report is being submitted based on analysis which revealed exposed wires in the catheter.
|
|
Search Alerts/Recalls
|
|
|