MalfunctionDRC
BRK¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH
Received Jun 17, 2026 · Event occurred Aug 31, 2025
Report 3008452825-2026-00344 · MDR key 25539610
Device
Generic name
Trocar
Manufacturer
Abbott MedicalModel number
407206Catalog number
407206
Lot number
10637597
Product problems
- Fluid/Blood Leak
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A LEAK OCCURRED FROM THE BRK NEEDLE. THE NEEDLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A SLIP TIP SYRINGE WAS USED AND THE NEEDLE WAS PRE-SHAPED.