PACEL FLOW DIRECTED PACING CATHETER
Received May 6, 2025 · Event occurred Dec 16, 2024
Report 2182269-2025-00022 · MDR key 21969955
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
St. Jude MedicalModel number
401764Catalog number
401764
Lot number
10394001
Product problems
- Inflation Problem
- Material Separation
- Inflation Problem
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ONE 5F PACEL (FLOW DIRECTED) PACING CATHETER WAS RECEIVED FOR EVALUATION. THE 1.25CC VOLUME LIMITED SYRINGE WAS ALSO RETURNED. THE REPORTED EVENT OF A RUPTURED BALLOON WAS CONFIRMED. THE BALLOON WAS NOTED TO BE TORN AND RUPTURED WHERE THE ADHESIVE SEAL MEETS THE BALLOON AT THE PROXIMAL END OF THE BALLOON. THE PROXIMAL AND DISTAL ADHESIVE BONDS FOR THE BALLOON REMAINED INTACT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE TORN AND RUPTURED BALLOON REMAINS UNKNOWN.
Description of Event or Problem
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A PACING CATHETER WAS INSERTED INTO THE PATIENT AND BLOOD RETURNED TO THE SYRINGE. THE CATHETER WAS REMOVED, AND THE TIP OF THE BALLOON WAS FOUND TO BE RUPTURED. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.