GUIDE WIRE 0.018"PTFE COATED
Received Dec 31, 2025 · Event occurred Sep 22, 2025
Report 1220648-2025-49705 · MDR key 23936288
Device
Generic name
Guidewire, Catheter
Manufacturer
Abiomed, Inc.Model number
GUIDE WIRE 0.018"PTFE COATEDCatalog number
0052-3005
Product problems
- Deformation Due to Compressive Stress
- Deformation Due to Compressive Stress
Patient
57 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B5 UPDATED.
Description of Event or Problem
THE COMPLAINANT REPORTED ADDITIONAL INFORMATION UPON REQUEST: "THE IMPELLA 5.5 HAD NO ISSUES AFTER THE INITIAL INSERTION. NO REPLACEMENT OF PUMP WAS NEEDED. THE DEVICE WAS DISPOSED AND NO OTHER INFORMATION IS AVAILABLE!".
Description of Event or Problem
IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPELLA 5.5 THERE WAS A PUMP STOP THAT PROMPTED THE PUMP TO BE REMOVED, REFLUSHED AND PLACED. THE WIRE WAS OBSERVED TO BE DAMAGED UPON REMOVAL/REPLACEMENT. LATER, THE PATIENT WAS SUCCESSFULLY WEANED FROM THE PUMP AND SURVIVED.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED. LOGS ARE NOT APPLICABLE. THE CAUSE OF THE GUIDEWIRE KINK WAS USE RELATED SINCE THE 0.018 GUIDEWIRE WAS LEFT IN THE PUMP WHEN STARTING IT.