RF NEEDLE
Received Nov 6, 2023 · Event occurred Oct 6, 2023
Report 2124215-2023-61167 · MDR key 18079117
Device
Product problems
- Detachment of Device or Device Component
- Device-Device Incompatibility
- Difficult to Advance
- Physical Resistance/Sticking
- Detachment of Device or Device Component
- Device-Device Incompatibility
- Difficult to Advance
- Physical Resistance/Sticking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A NRG RF NEEDLE WAS SELECTED FOR USE DURING A MITRAL CLIP PROCEDURE. DURING THE PROCEDURE, WHEN IT WAS TRIED TO INSERT THE NRG NEEDLE INSIDE A NON-BOSTON SCIENTIFIC SHEATH, IT WAS FELT LIKE IT WAS STUCK AND THE TIP GOT BROKEN. THE DAMAGED TIP WAS NOTICED WHEN PHYSICIAN TRIED TO PUT IT INSIDE THE NON-BOSTON SCIENTIFIC SHEATH. WHEN PHYSICIAN TRIED TO PUT IT INSIDE THE SHEATH, FELT IT GET CAUGHT AND THE TIP BROKE. THE PHYSICIAN EXPERIENCED RESISTANCE WHEN TRACKING THE DEVICE THROUGH ACCESSORY DEVICES. THUS, THE BROKEN NRG NEEDLE WAS RETRIEVED, AND IT WAS REPLACED WITH ANOTHER NRG NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Additional Manufacturer Narrative
IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.