AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Jun 20, 2025 · Event occurred Jun 3, 2025
Report 2017865-2025-87353 · MDR key 22301873
Product problems
- Connection Problem
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING INITIAL IMPLANT PROCEDURE, THE RETRIEVAL CATHETER FAILED TO RETRIEVE THE DEVICE. THE DEVICE RETRIEVAL PROCESS WAS SIGNIFICANTLY PROLONGED AND THE DEVICE WAS RETRIEVED USING A SEPARATE SHEATH AND SNARE. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Additional Manufacturer Narrative
PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER CANNOT BE PROVIDED AS A PRODUCT IDENTIFIER COULD NOT BE OBTAINED.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.