inforMED
MalfunctionQLZ

REPROCESSED NRG TRANSSEPTAL NEEDLE, 71 CM

Received Apr 7, 2023 · Event occurred Feb 22, 2023

Report 16700593 · MDR key 16700593

Device

Generic name

Septostomy Catheter, Reprocessed

Catalog number

NRG-E-HF-71-C1

Lot number

100096947

Product problems

  • Protective Measures Problem

Patient

26645 DA · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ELDERLY MALE PATIENT, WHILE UNDERGOING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE BAYLIS REPROCESSED TRANS-SEPTAL NEEDLE WAS INSERTED INTO THE ST. JUDE¿S SL-0 SHEATH TO PERFORM THE TRANS-SEPTAL PUNCTURE UNDER ICE (INTRACARDIAC ECHOCARDIOGRAPHY) VIEWS. THE REPROCESSED BAYLIS NEEDLE WAS NOTED TO BE NOT REGISTERING WITH THE BAYLIS RF GENERATOR. THE "ALERT A015" CODE WAS NOTED-INVALID DEVICE DETECTED. RECORD ALERT CODE AND CONTACT BAYLIS CLINICAL SUPPORT." ANOTHER REPROCESSED BAYLIS NEEDLE WAS USED IN PLACE OF THE FIRST NEEDLE AND WORKED PROPERLY. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT AND THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR NEELE, TRANS-SEPTAL NEEDLE (PER SITE REPORTER) THE MEDLINE CUSTOMER SUPPORT WAS NOTIFIED.